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Trial record 2 of 2 for:    212390

Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)

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ClinicalTrials.gov Identifier: NCT04187144
Recruitment Status : Completed
First Posted : December 5, 2019
Results First Posted : July 18, 2023
Last Update Posted : July 18, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Urinary Tract Infections
Interventions Drug: Gepotidacin
Drug: Placebo matching nitrofurantoin
Drug: Nitrofurantoin
Drug: Placebo matching gepotidacin
Enrollment 1606
Recruitment Details 1605 unique participants were enrolled in the study including one participant that was randomized twice in error. This participant signed two different informed consent forms, therefore that participant was counted as enrolling twice.
Pre-assignment Details  
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water. Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Period Title: Overall Study
Started [1] 805 800
Safety Population [2] 804 798
Microbiological ITT (Micro ITT) Population [3] 331 324
Micro-ITT NTF-S Population [4] 292 275
Micro-ITT NTF-S (IA Set) Population [5] 277 264
Completed 748 759
Not Completed 57 41
Reason Not Completed
Lost to Follow-up             12             11
Withdrawal by Subject             20             18
Adverse Event             19             4
Physician Decision             5             3
Screening Failure due to creatinine clearance and body mass index             0             1
Protocol Deviation             1             4
[1]
Participants randomly assigned to the study treatment were included in Intent-to-Treat (ITT) population
[2]
Safety population included all randomized participants who receive at least 1 dose of study treatment.
[3]
Microbiological ITT (micro-ITT) population included all participants randomly assigned to study treatment who receive at least 1 dose of study treatment and have a qualifying baseline uropathogen [10^5 CFU/mL] from a quantitative bacteriological culture of a pretreatment clean catch midstream urine specimen.
[4]
Micro-ITT NTF-S population is defined as all participants in the micro-ITT population whose baseline qualifying uropathogens [10^5 CFU/mL] are all susceptible to nitrofurantoin (NTF-S).
[5]
Microbiological intent-to-treat susceptible to nitrofurantoin (micro-ITT NTF-S) (IA Set) population included participants in the micro ITT NTF-S who per the interim analysis data had the opportunity to reach their Test of Cure (TOC) visit, or had not yet reached their TOC visit, but were already known to be failures.
Arm/Group Title Gepotidacin Nitrofurantoin Total
Hide Arm/Group Description Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water. Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water. Total of all reporting groups
Overall Number of Baseline Participants 805 800 1605
Hide Baseline Analysis Population Description
Participants randomly assigned to the study treatment were included in the ITT population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 805 participants 800 participants 1605 participants
48.2  (17.84) 48.4  (17.72) 48.3  (17.77)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 805 participants 800 participants 1605 participants
Less than (<) 18 years
8
   1.0%
3
   0.4%
11
   0.7%
More than or equal to (>=) 18 years to 50 years
427
  53.0%
430
  53.8%
857
  53.4%
More than (>) 50 years
370
  46.0%
367
  45.9%
737
  45.9%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 805 participants 800 participants 1605 participants
805
 100.0%
800
 100.0%
1605
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 805 participants 800 participants 1605 participants
Hispanic or Latino
246
  30.6%
232
  29.0%
478
  29.8%
Not Hispanic or Latino
559
  69.4%
568
  71.0%
1127
  70.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 805 participants 800 participants 1605 participants
American Indian or Alaska Native
2
   0.2%
1
   0.1%
3
   0.2%
Asian
51
   6.3%
65
   8.1%
116
   7.2%
Native Hawaiian or Other Pacific Islander
1
   0.1%
0
   0.0%
1
   0.1%
Black or African American
74
   9.2%
62
   7.8%
136
   8.5%
White
674
  83.7%
668
  83.5%
1342
  83.6%
More than one race
2
   0.2%
4
   0.5%
6
   0.4%
Unknown or Not Reported
1
   0.1%
0
   0.0%
1
   0.1%
Baseline Acute Cystitis Recurrence   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 805 participants 800 participants 1605 participants
Recurrent Infection
334
  41.5%
338
  42.3%
672
  41.9%
Non-Recurrent Infection
471
  58.5%
462
  57.8%
933
  58.1%
[1]
Measure Description: Recurrent infection was defined as a confirmed infection with at least 1 episode within the past 3 months, at least 2 episodes within the past 6 months, or at least 3 episodes within the past 12 months before study entry.
1.Primary Outcome
Title Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set)
Hide Description TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at Baseline [BL] to <10^3 colony forming units per milliliter [CFU/mL] without receiving other systemic antimicrobials [AB] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no symptoms without receiving other AB before the TOC visit [or AB for uUTI on day of TOC visit]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Time Frame TOC visit (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Microbiological intent-to-treat susceptible to nitrofurantoin - (Micro-ITT NTF-S) (Interim Analysis [IA] Set) population included participants in the micro ITT NTF-S who per the interim analysis data had the opportunity to reach their Test of Cure (TOC) visit, or had not yet reached their TOC visit, but were already known to be failures.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 277 264
Measure Type: Count of Participants
Unit of Measure: Participants
Therapeutic Success
162
  58.5%
115
  43.6%
Therapeutic Failure
115
  41.5%
149
  56.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gepotidacin, Nitrofurantoin
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the 2.098 Z-statistic boundary.
Method of Estimation Estimation Parameter Adjusted Difference in Percent
Estimated Value 14.6
Confidence Interval (2-Sided) 95%
6.4 to 22.8
Estimation Comments [Not Specified]
Other Statistical Analysis Observed Z statistic value for Noninferiority was 5.8838.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gepotidacin, Nitrofurantoin
Comments The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.018 p-value boundary
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method 1-sided p-value for Test of Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted difference in Percent
Estimated Value 14.6
Confidence Interval (2-Sided) 95%
6.4 to 22.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population
Hide Description TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at Baseline [BL] to <10^3 colony forming units per milliliter [CFU/mL] without receiving other systemic antimicrobials [AB] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit [or AB for uUTI on day of TOC visit]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Time Frame TOC visit (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Micro-ITT NTF-S population
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 292 275
Measure Type: Count of Participants
Unit of Measure: Participants
Therapeutic Success
172
  58.9%
121
  44.0%
Therapeutic Failure
120
  41.1%
154
  56.0%
3.Secondary Outcome
Title Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Hide Description Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at baseline (BL) (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
Time Frame TOC visit (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Micro-ITT NTF-S population
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 292 275
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical Resolution
199
  68.2%
175
  63.6%
Clinical Improvement (CI)
51
  17.5%
68
  24.7%
Clinical Worsening (CW)
20
   6.8%
17
   6.2%
Unable to Determine
22
   7.5%
15
   5.5%
4.Secondary Outcome
Title Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population
Hide Description Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.
Time Frame TOC visit (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Micro-ITT NTF-S population.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 292 275
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical Success
199
  68.2%
175
  63.6%
Clinical Failure
93
  31.8%
100
  36.4%
5.Secondary Outcome
Title Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population
Hide Description Participant-level MOs at TOC were categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., <10^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.
Time Frame TOC Visit (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Micro-ITT NTF-S population.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 292 275
Measure Type: Count of Participants
Unit of Measure: Participants
Microbiological Eradication (ME)
213
  72.9%
158
  57.5%
Microbiological Persistence (MP)
13
   4.5%
31
  11.3%
Microbiological Recurrence (MR)
19
   6.5%
52
  18.9%
Unable to Determine (UTD)
47
  16.1%
34
  12.4%
6.Secondary Outcome
Title Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population
Hide Description Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP)s had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.
Time Frame TOC visit (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Micro-ITT NTF-S population.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 292 275
Measure Type: Count of Participants
Unit of Measure: Participants
Microbiological Success
213
  72.9%
158
  57.5%
Microbiological Failure
79
  27.1%
117
  42.5%
7.Secondary Outcome
Title Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Hide Description TR at FU was categorized as therapeutic success and therapeutic failure. A therapeutic success at FU referred to participants who have been deemed both a microbiological success (reduction of all QUPs recovered at BL to <10^3 CFU/mL, following microbiological eradication at the TOC visit, without receiving other AB before the FU visit) and a clinical success (resolution of signs and symptoms of acute cystitis demonstrated at the TOC visit persist at the FU visit and no new signs and symptoms, without receiving other AB before the FU visit [or AB for uUTI on day of FU visit]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Time Frame FU visit (Days 21 to 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Micro-ITT NTF-S population.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 292 275
Measure Type: Count of Participants
Unit of Measure: Participants
Therapeutic Success
126
  43.2%
95
  34.5%
Therapeutic Failure
166
  56.8%
180
  65.5%
8.Secondary Outcome
Title Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Hide Description Clinical outcomes at FU were categorized as SCR, DCR, CI, CW, CR and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at the TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. Unable to determine outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for the current infection (uUTI) prior to the assessment (unless CS or CR outcome criteria were met).
Time Frame FU visit (Days 21 to 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Micro-ITT NTF-S population
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 292 275
Measure Type: Count of Participants
Unit of Measure: Participants
Sustained Clinical Resolution (SCR)
168
  57.5%
154
  56.0%
Delayed Clinical Resolution (DCR)
34
  11.6%
35
  12.7%
Clinical Improvement (CI)
15
   5.1%
19
   6.9%
Clinical Worsening (CW)
26
   8.9%
32
  11.6%
Clinical Recurrence (CR)
8
   2.7%
7
   2.5%
Unable to Determine (UTD)
41
  14.0%
28
  10.2%
9.Secondary Outcome
Title Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Hide Description Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
Time Frame FU visit (Days 21 to 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Micro-ITT NTF-S population
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 292 275
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical Success
168
  57.5%
154
  56.0%
Clinical Failure
124
  42.5%
121
  44.0%
10.Secondary Outcome
Title Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Hide Description Participant-level MOs at FU were categorized as sustained microbiological eradication (SME), microbiological recurrence (MR), microbiological persistence (MP), delayed microbiological eradication (DME) and unable to determine (UTD). SME at FU was defined as all baseline QUPs had an outcome of sustained eradication at FU (i.e., <10^3 CFU/mL without the participant receiving other systemic antimicrobials before the FU Visit). MR at FU was defined as at least one QUP had an outcome of recurrence (≥10^3 CFU/mL) and none had an outcome of persistence at FU. MP at FU was defined as at least one QUP had an outcome of persistence at FU. DME at FU was defined as at least one QUP had an outcome of delayed eradication and none had an outcome of persistence or recurrence at FU. UTD at FU was defined as all QUP outcomes were unable to determine at FU.
Time Frame FU visit (Days 21 to 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Micro-ITT NTF-S population.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 292 275
Measure Type: Count of Participants
Unit of Measure: Participants
Sustained Microbiological Eradication (SME)
154
  52.7%
119
  43.3%
Microbiological Persistence (MP)
19
   6.5%
44
  16.0%
Microbiological Recurrence (MR)
29
   9.9%
23
   8.4%
Delayed Microbiological Eradication (DME)
20
   6.8%
28
  10.2%
Unable to Determine (UTD)
70
  24.0%
61
  22.2%
11.Secondary Outcome
Title Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Hide Description Participant- level microbiological response at FU was categorized as microbiological success and microbiological failure. Microbiological success at FU was defined as all baseline QUPs had a microbiological outcome of sustained eradication at FU visit. Microbiological failure at FU was defined as not meeting criteria of microbiological success including those participants with UTD outcome.
Time Frame FU visit (Days 21 to 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Micro-ITT NTF-S population.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 292 275
Measure Type: Count of Participants
Unit of Measure: Participants
Microbiological Success
154
  52.7%
119
  43.3%
Microbiological Failure
138
  47.3%
156
  56.7%
12.Secondary Outcome
Title Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population
Hide Description Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution symptoms of acute cystitis present at baseline (BL) (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
Time Frame TOC visit (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population included all participants randomly assigned to study treatment.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 805 800
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical Resolution
549
  68.2%
517
  64.6%
Clinical Improvement
153
  19.0%
199
  24.9%
Clinical Worsening
36
   4.5%
39
   4.9%
Unable to Determine
67
   8.3%
45
   5.6%
13.Secondary Outcome
Title Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population
Hide Description Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure.
Time Frame TOC visit (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 805 800
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical Success
549
  68.2%
517
  64.6%
Clinical Failure
256
  31.8%
283
  35.4%
14.Secondary Outcome
Title Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Hide Description Clinical outcomes at FU were categorized as Sustained Clinical Response (SCR), Delayed Clinical Response (DCR), CI, CW, Clinical Recurrence (CR) and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. UTD outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for current infection (uUTI) prior to assessment (unless CS or CR outcome criteria were met).
Time Frame FU visit (Days 21 to 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 805 800
Measure Type: Count of Participants
Unit of Measure: Participants
Sustained Clinical Resolution (SCR)
478
  59.4%
443
  55.4%
Delayed Clinical Resolution (DCR)
108
  13.4%
116
  14.5%
Clinical Improvement (CI)
40
   5.0%
52
   6.5%
Clinical Worsening (CW)
51
   6.3%
65
   8.1%
Clinical Recurrence (CR)
25
   3.1%
28
   3.5%
Unable to Determine (UTD)
103
  12.8%
96
  12.0%
15.Secondary Outcome
Title Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Hide Description Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
Time Frame FU visit (Days 21 to 31)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 805 800
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical Success
478
  59.4%
443
  55.4%
Clinical Failure
327
  40.6%
357
  44.6%
16.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
Time Frame From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who receive at least 1 dose of study treatment.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 804 798
Measure Type: Count of Participants
Unit of Measure: Participants
285
  35.4%
200
  25.1%
17.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.
Time Frame From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who receive at least 1 dose of study treatment.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 804 798
Measure Type: Count of Participants
Unit of Measure: Participants
5
   0.6%
5
   0.6%
18.Secondary Outcome
Title Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Hide Description Blood samples were collected for the analysis of hematology parameters: neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 736 737
Mean (Standard Deviation)
Unit of Measure: Giga cells per Liter (10^9 cells/L)
Eosinophils, Baseline Number Analyzed 702 participants 698 participants
0.161  (0.1350) 0.163  (0.1331)
Eosinophils, On-Therapy Number Analyzed 622 participants 606 participants
0.006  (0.0841) 0.013  (0.0814)
Eosinophils, Test of Cure Number Analyzed 608 participants 599 participants
0.015  (0.0906) 0.018  (0.1081)
Basophils, Baseline Number Analyzed 642 participants 668 participants
0.054  (0.0227) 0.053  (0.0228)
Basophils, On-Therapy Number Analyzed 533 participants 550 participants
-0.001  (0.0195) 0.001  (0.0194)
Basophils, Test of Cure Number Analyzed 528 participants 551 participants
0.000  (0.0209) 0.001  (0.0183)
Lymphocytes, Baseline Number Analyzed 736 participants 737 participants
2.091  (0.6954) 2.121  (0.7122)
Lymphocytes, On-Therapy Number Analyzed 661 participants 657 participants
-0.018  (0.4523) -0.076  (0.5051)
Lymphocytes, Test of Cure Number Analyzed 641 participants 651 participants
-0.010  (0.5292) 0.059  (0.5839)
Monocytes, Baseline Number Analyzed 736 participants 737 participants
0.529  (0.1803) 0.525  (0.1790)
Monocytes, On-Therapy Number Analyzed 661 participants 657 participants
-0.020  (0.1487) 0.003  (0.1711)
Monocytes, Test of Cure Number Analyzed 641 participants 651 participants
-0.029  (0.1731) -0.012  (0.1778)
Neutrophils, Baseline Number Analyzed 736 participants 737 participants
4.582  (1.8893) 4.755  (1.8821)
Neutrophils, On-Therapy Number Analyzed 661 participants 656 participants
-0.490  (1.6201) -0.453  (1.7453)
Neutrophils, Test of Cure Number Analyzed 641 participants 651 participants
-0.534  (2.0207) -0.494  (1.9072)
Platelets, Baseline Number Analyzed 723 participants 729 participants
280.3  (68.46) 287.2  (73.51)
Platelets, On-Therapy Number Analyzed 649 participants 648 participants
-1.1  (33.03) -2.5  (36.67)
Platelets, Test of Cure Number Analyzed 626 participants 637 participants
6.8  (42.12) 5.5  (58.04)
19.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Hemoglobin Level
Hide Description Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 739 737
Mean (Standard Deviation)
Unit of Measure: Gram per Liter (g/L)
Baseline Number Analyzed 739 participants 737 participants
132.5  (13.25) 131.7  (14.28)
On-Therapy Number Analyzed 665 participants 657 participants
-1.5  (6.74) -1.9  (6.82)
Test of Cure Number Analyzed 643 participants 653 participants
-1.3  (7.44) -1.4  (8.33)
20.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Hematocrit Level
Hide Description Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 739 737
Mean (Standard Deviation)
Unit of Measure: Percentage of hematocrit
Baseline Number Analyzed 739 participants 737 participants
0.4314  (0.04146) 0.4292  (0.04348)
On-Therapy Number Analyzed 665 participants 657 participants
-0.0033  (0.02832) -0.0041  (0.02715)
Test of Cure Number Analyzed 643 participants 653 participants
-0.0045  (0.02806) -0.0029  (0.03194)
21.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count
Hide Description Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 739 737
Mean (Standard Deviation)
Unit of Measure: Tera cells per Liter (10^12 cells/L)
Baseline Number Analyzed 739 participants 737 participants
4.539  (0.4211) 4.539  (0.4379)
On-Therapy Number Analyzed 665 participants 657 participants
-0.046  (0.2309) -0.060  (0.2513)
Test of Cure Number Analyzed 643 participants 653 participants
-0.038  (0.2634) -0.049  (0.3052)
22.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Hide Description Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 739 737
Mean (Standard Deviation)
Unit of Measure: Picogram (pg)
Baseline Number Analyzed 739 participants 737 participants
29.28  (2.537) 29.09  (2.644)
On-Therapy Number Analyzed 665 participants 657 participants
-0.02  (0.795) -0.02  (0.820)
Test of Cure Number Analyzed 643 participants 653 participants
-0.04  (0.780) 0.02  (0.917)
23.Secondary Outcome
Title Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Hide Description Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 739 737
Mean (Standard Deviation)
Unit of Measure: Femtolitre (fL)
Baseline Number Analyzed 739 participants 737 participants
95.30  (7.191) 94.82  (7.511)
On-Therapy Number Analyzed 665 participants 657 participants
0.26  (4.287) 0.35  (4.303)
Test of Cure Number Analyzed 643 participants 653 participants
-0.15  (4.049) 0.39  (4.730)
24.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 781 777
Mean (Standard Deviation)
Unit of Measure: millimoles per liter (mmol/L)
Serum Urea Nitrogen, Baseline Number Analyzed 780 participants 776 participants
4.742  (2.1107) 4.724  (1.8645)
Serum Urea Nitrogen, On- Therapy Number Analyzed 714 participants 721 participants
-0.056  (1.4269) -0.018  (1.1663)
Serum Urea Nitrogen, Test of Cure Number Analyzed 703 participants 716 participants
0.022  (1.4000) 0.131  (1.4826)
Serum Calcium, Baseline Number Analyzed 776 participants 773 participants
2.363  (0.1196) 2.362  (0.1083)
Serum Calcium, On-Therapy Number Analyzed 705 participants 717 participants
-0.010  (0.0950) -0.018  (0.0944)
Serum Calcium, Test of Cure Number Analyzed 698 participants 712 participants
-0.014  (0.1070) -0.016  (0.0981)
Serum Chloride, Baseline Number Analyzed 780 participants 776 participants
101.0  (3.27) 100.9  (3.27)
Serum Chloride, On-Therapy Number Analyzed 713 participants 721 participants
0.3  (2.80) 0.1  (2.85)
Serum Chloride, Test of Cure Number Analyzed 701 participants 716 participants
0.4  (2.93) 0.4  (3.02)
Serum Glucose, Baseline Number Analyzed 777 participants 774 participants
5.590  (1.9980) 5.719  (2.1915)
Serum Glucose, On-Therapy Number Analyzed 705 participants 719 participants
0.230  (1.5120) 0.328  (1.9380)
Serum Glucose, Test of Cure Number Analyzed 698 participants 709 participants
0.215  (1.4412) 0.266  (1.6667)
Serum Magnesium, Baseline Number Analyzed 776 participants 773 participants
0.839  (0.0749) 0.835  (0.0802)
Serum Magnesium, On-Therapy Number Analyzed 706 participants 717 participants
-0.001  (0.0635) -0.015  (0.0616)
Serum Magnesium, Test of Cure Number Analyzed 698 participants 712 participants
-0.011  (0.0674) -0.015  (0.0689)
Serum Potassium, Baseline Number Analyzed 776 participants 772 participants
4.32  (0.414) 4.27  (0.415)
Serum Potassium, On-Therapy Number Analyzed 701 participants 717 participants
-0.04  (0.417) -0.03  (0.428)
Serum Potassium, Test of Cure Number Analyzed 696 participants 710 participants
-0.03  (0.438) 0.00  (0.461)
Serum Phosphate, Baseline Number Analyzed 778 participants 774 participants
1.141  (0.1828) 1.139  (0.1725)
Serum Phosphate, On-Therapy Number Analyzed 704 participants 719 participants
-0.005  (0.1782) -0.027  (0.1836)
Serum Phosphate, Test of Cure Number Analyzed 699 participants 711 participants
0.002  (0.1851) -0.004  (0.1939)
Serum Sodium, Baseline Number Analyzed 781 participants 777 participants
138.8  (2.64) 138.8  (2.76)
Serum Sodium, On-Therapy Number Analyzed 714 participants 724 participants
0.0  (2.64) -0.2  (2.64)
Serum Sodium, Test of Cure Number Analyzed 702 participants 717 participants
0.2  (2.91) 0.1  (2.91)
25.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 779 776
Mean (Standard Deviation)
Unit of Measure: micromoles per Liter (umol/L)
Serum Direct Bilirubin, Baseline Number Analyzed 93 participants 84 participants
4.61  (1.669) 4.47  (1.128)
Serum Direct Bilirubin, On- Therapy Number Analyzed 50 participants 41 participants
-0.18  (1.192) -0.18  (1.114)
Serum Direct Bilirubin, Test of Cure Number Analyzed 46 participants 38 participants
-0.19  (1.059) 0.15  (1.288)
Serum Total Bilirubin, Baseline Number Analyzed 751 participants 742 participants
6.57  (3.940) 6.56  (3.518)
Serum Total Bilirubin, On-Therapy Number Analyzed 655 participants 670 participants
-0.28  (2.510) -0.42  (2.672)
Serum Total Bilirubin, Test of Cure Number Analyzed 652 participants 656 participants
-0.01  (2.976) -0.29  (3.230)
Serum Creatinine, Baseline Number Analyzed 779 participants 776 participants
58.8  (30.59) 58.1  (17.22)
Serum Creatinine, On-Therapy Number Analyzed 712 participants 721 participants
0.8  (30.31) 0.3  (10.31)
Serum Creatinine, Test of Cure Number Analyzed 703 participants 715 participants
1.7  (14.00) 1.5  (13.40)
26.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 781 777
Mean (Standard Deviation)
Unit of Measure: gram per Liter (g/L)
Serum Albumin, Baseline Number Analyzed 781 participants 777 participants
45.2  (3.33) 45.2  (3.11)
Serum Albumin, On-Therapy Number Analyzed 715 participants 725 participants
-0.4  (2.38) -0.8  (2.56)
Serum Albumin, Test of Cure Number Analyzed 705 participants 720 participants
-0.5  (2.65) -0.6  (2.84)
Serum Protein, Baseline Number Analyzed 778 participants 774 participants
71.5  (5.12) 71.6  (4.72)
Serum Protein, On-Therapy Number Analyzed 709 participants 719 participants
-0.7  (3.71) -1.2  (3.89)
Serum Protein, Test of Cure Number Analyzed 700 participants 711 participants
-1.0  (4.19) -1.1  (4.32)
27.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
Hide Description Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 777 774
Mean (Standard Deviation)
Unit of Measure: Units per Liter (U/L)
Serum ALT, Baseline Number Analyzed 776 participants 773 participants
20.3  (20.34) 19.5  (14.66)
Serum ALT, On-Therapy Number Analyzed 705 participants 716 participants
0.2  (10.8) -0.1  (7.9)
Serum ALT, Test of Cure Number Analyzed 699 participants 710 participants
0.4  (15.81) -0.2  (9.93)
Serum AST, Baseline Number Analyzed 777 participants 774 participants
21.0  (13.72) 20.2  (10.48)
Serum AST, On-Therapy Number Analyzed 706 participants 719 participants
0.1  (9.83) 0.0  (7.90)
Serum AST, Test of Cure Number Analyzed 700 participants 710 participants
0.9  (9.89) -0.5  (8.29)
Serum ALP, Baseline Number Analyzed 776 participants 773 participants
81.4  (29.96) 81.7  (28.99)
Serum ALP, On- Therapy Number Analyzed 707 participants 717 participants
-0.5  (9.61) -0.1  (12.91)
Serum ALP, Test of Cure Number Analyzed 698 participants 712 participants
-1.0  (12.00) -0.4  (15.38)
28.Secondary Outcome
Title Number of Participants With Urinalysis Dipstick Results
Hide Description Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Protein (PRO), Urine Occult Blood (BLO), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Leukocyte Esterase (LEU). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, Small, Moderate, Large, Positive, 50 milligram per deciliter (mg/dL), 150 mg/dL, >=500 mg/dL, 30 mg/dL, 100 mg/dL, 200 mg/dL, 5 mg/dL, 20 mg/dL, >=80 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, Negative), GLU indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Data is presented in similar way for others parameters.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 789 783
Measure Type: Count of Participants
Unit of Measure: Participants
GLU, Baseline, Negative Number Analyzed 779 participants 773 participants
751
  96.4%
738
  95.5%
GLU, Baseline, 50 mg/dL Number Analyzed 779 participants 773 participants
4
   0.5%
5
   0.6%
GLU, Baseline, 150 mg/dL Number Analyzed 779 participants 773 participants
3
   0.4%
4
   0.5%
GLU, Baseline, >= 500 mg/dL Number Analyzed 779 participants 773 participants
21
   2.7%
26
   3.4%
GLU, On-Therapy, Negative Number Analyzed 731 participants 737 participants
700
  95.8%
697
  94.6%
GLU, On-Therapy, 50 mg/dL Number Analyzed 731 participants 737 participants
7
   1.0%
7
   0.9%
GLU, On-Therapy, 150 mg/dL Number Analyzed 731 participants 737 participants
1
   0.1%
5
   0.7%
GLU, On-Therapy, >= 500 mg/dL Number Analyzed 731 participants 737 participants
23
   3.1%
28
   3.8%
GLU, Test of Cure, Negative Number Analyzed 719 participants 727 participants
686
  95.4%
693
  95.3%
GLU, Test of Cure, 50 mg/dL Number Analyzed 719 participants 727 participants
9
   1.3%
10
   1.4%
GLU, Test of Cure, 150 mg/dL Number Analyzed 719 participants 727 participants
12
   1.7%
4
   0.6%
GLU, Test of Cure, >= 500 mg/dL Number Analyzed 719 participants 727 participants
12
   1.7%
20
   2.8%
PRO, Baseline, Negative Number Analyzed 778 participants 769 participants
524
  67.4%
529
  68.8%
PRO, Baseline, 30 mg/dL Number Analyzed 778 participants 769 participants
171
  22.0%
149
  19.4%
PRO, Baseline, 100 mg/dL Number Analyzed 778 participants 769 participants
78
  10.0%
85
  11.1%
PRO, Baseline, >=500 mg/dL Number Analyzed 778 participants 769 participants
5
   0.6%
6
   0.8%
PRO, On-Therapy, Negative Number Analyzed 731 participants 737 participants
575
  78.7%
631
  85.6%
PRO, On-Therapy, 30 mg/dL Number Analyzed 731 participants 737 participants
110
  15.0%
83
  11.3%
PRO, On-Therapy, 100 mg/dL Number Analyzed 719 participants 727 participants
43
   6.0%
19
   2.6%
PRO, On-Therapy, >=500 mg/dL Number Analyzed 731 participants 737 participants
3
   0.4%
4
   0.5%
PRO, Test of Cure, Negative Number Analyzed 719 participants 727 participants
605
  84.1%
605
  83.2%
PRO, Test of Cure, 30 mg/dL Number Analyzed 719 participants 727 participants
88
  12.2%
88
  12.1%
PRO, Test of Cure, 100 mg/dL Number Analyzed 731 participants 737 participants
25
   3.4%
34
   4.6%
PRO, Test of Cure, >=500 mg/dL Number Analyzed 719 participants 727 participants
1
   0.1%
0
   0.0%
BLO, Baseline, Positive Number Analyzed 784 participants 777 participants
0
   0.0%
2
   0.3%
BLO, Baseline, Negative Number Analyzed 784 participants 777 participants
345
  44.0%
348
  44.8%
BLO, Baseline, Trace Number Analyzed 784 participants 777 participants
2
   0.3%
0
   0.0%
BLO, Baseline, Small Number Analyzed 784 participants 777 participants
229
  29.2%
217
  27.9%
BLO, Baseline, Moderate Number Analyzed 784 participants 777 participants
128
  16.3%
129
  16.6%
BLO, Baseline, Large Number Analyzed 784 participants 777 participants
80
  10.2%
81
  10.4%
BLO, On-Therapy, Negative Number Analyzed 731 participants 737 participants
560
  76.6%
520
  70.6%
BLO, On-Therapy, Small Number Analyzed 731 participants 737 participants
116
  15.9%
161
  21.8%
BLO, On-Therapy, Moderate Number Analyzed 731 participants 737 participants
23
   3.1%
30
   4.1%
BLO, On-Therapy, Large Number Analyzed 731 participants 737 participants
32
   4.4%
26
   3.5%
BLO, Test of Cure, Negative Number Analyzed 719 participants 727 participants
517
  71.9%
511
  70.3%
BLO, Test of Cure, Small Number Analyzed 719 participants 727 participants
128
  17.8%
139
  19.1%
BLO, Test of Cure, Moderate Number Analyzed 719 participants 727 participants
49
   6.8%
45
   6.2%
BLO, Test of Cure, Large Number Analyzed 719 participants 727 participants
25
   3.5%
32
   4.4%
KET, Baseline, Negative Number Analyzed 779 participants 773 participants
754
  96.8%
748
  96.8%
KET, Baseline, 5 mg/dL Number Analyzed 779 participants 773 participants
14
   1.8%
18
   2.3%
KET, Baseline, 20 mg/dL Number Analyzed 779 participants 773 participants
11
   1.4%
7
   0.9%
KET, On-Therapy, Negative Number Analyzed 731 participants 737 participants
712
  97.4%
699
  94.8%
KET, On-Therapy, 5 mg/dL Number Analyzed 731 participants 737 participants
14
   1.9%
22
   3.0%
KET, On-Therapy, 20 mg/dL Number Analyzed 731 participants 737 participants
5
   0.7%
15
   2.0%
KET, On-Therapy, >=80 mg/dL Number Analyzed 731 participants 737 participants
0
   0.0%
1
   0.1%
KET, Test of Cure, Negative Number Analyzed 719 participants 727 participants
706
  98.2%
700
  96.3%
KET, Test of Cure, 5 mg/dL Number Analyzed 719 participants 727 participants
7
   1.0%
20
   2.8%
KET, Test of Cure, 20 mg/dL Number Analyzed 719 participants 727 participants
6
   0.8%
7
   1.0%
NIT, Baseline, Negative Number Analyzed 789 participants 783 participants
552
  70.0%
531
  67.8%
NIT, Baseline, Positive Number Analyzed 789 participants 783 participants
237
  30.0%
252
  32.2%
NIT, On-Therapy, Negative Number Analyzed 731 participants 737 participants
694
  94.9%
697
  94.6%
NIT, On-Therapy, Positive Number Analyzed 731 participants 737 participants
37
   5.1%
40
   5.4%
NIT, Test of Cure, Negative Number Analyzed 719 participants 727 participants
697
  96.9%
669
  92.0%
NIT, Test of Cure, Positive Number Analyzed 719 participants 727 participants
22
   3.1%
58
   8.0%
LEU, Baseline, Negative Number Analyzed 789 participants 782 participants
245
  31.1%
232
  29.7%
LEU, Baseline, Trace Number Analyzed 789 participants 782 participants
96
  12.2%
91
  11.6%
LEU, Baseline, Small Number Analyzed 789 participants 782 participants
75
   9.5%
80
  10.2%
LEU, Baseline, Moderate Number Analyzed 789 participants 782 participants
120
  15.2%
116
  14.8%
LEU, Baseline, Large Number Analyzed 789 participants 782 participants
251
  31.8%
262
  33.5%
LEU, Baseline, Missing Number Analyzed 789 participants 782 participants
2
   0.3%
1
   0.1%
LEU, On-Therapy, Negative Number Analyzed 731 participants 737 participants
510
  69.8%
475
  64.5%
LEU, On-Therapy, Trace Number Analyzed 731 participants 737 participants
79
  10.8%
82
  11.1%
LEU, On-Therapy, Small Number Analyzed 731 participants 737 participants
50
   6.8%
49
   6.6%
LEU, On-Therapy, Moderate Number Analyzed 731 participants 737 participants
34
   4.7%
57
   7.7%
LEU, On-Therapy, Large Number Analyzed 731 participants 737 participants
58
   7.9%
74
  10.0%
LEU, Test of Cure, Negative Number Analyzed 719 participants 727 participants
526
  73.2%
494
  68.0%
LEU, Test of Cure, Trace Number Analyzed 719 participants 727 participants
61
   8.5%
49
   6.7%
LEU, Test of Cure, Small Number Analyzed 719 participants 727 participants
43
   6.0%
48
   6.6%
LEU, Test of Cure, Moderate Number Analyzed 719 participants 727 participants
35
   4.9%
59
   8.1%
LEU, Test of Cure, Large Number Analyzed 719 participants 727 participants
54
   7.5%
77
  10.6%
29.Secondary Outcome
Title Absolute Mean Values of Urine Specific Gravity
Hide Description Urine samples were collected from participants to assess urine specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 779 773
Mean (Standard Deviation)
Unit of Measure: Ratio
Baseline Number Analyzed 779 participants 773 participants
1.0172  (0.00693) 1.0174  (0.00686)
On-Therapy Number Analyzed 731 participants 737 participants
1.0176  (0.00716) 1.0167  (0.00696)
Test of Cure Number Analyzed 719 participants 727 participants
1.0179  (0.00712) 1.0179  (0.00719)
30.Secondary Outcome
Title Absolute Mean Values of Urine Potential of Hydrogen (pH)
Hide Description Urine samples were collected from participants to assess urine pH levels. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 763 764
Mean (Standard Deviation)
Unit of Measure: pH
pH, Baseline Number Analyzed 763 participants 764 participants
5.7  (0.8) 5.7  (0.79)
pH, On-Therapy Number Analyzed 726 participants 733 participants
5.6  (0.66) 5.6  (0.69)
pH, Test of Cure Number Analyzed 716 participants 726 participants
5.6  (0.69) 5.7  (0.71)
31.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
Hide Description SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 804 798
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
SBP, Baseline Number Analyzed 804 participants 798 participants
122  (13.33) 122.7  (13.98)
SBP, On-Therapy Number Analyzed 745 participants 751 participants
-1.1  (10.14) -1.1  (10.72)
SBP, Test of Cure Number Analyzed 732 participants 752 participants
-0.4  (11.67) -1.8  (12.19)
DBP, Baseline Number Analyzed 804 participants 798 participants
76.9  (8.17) 77  (9)
DBP, On-Therapy Number Analyzed 745 participants 751 participants
-0.5  (7.30) -0.6  (7.73)
DBP, Test of Cure Number Analyzed 732 participants 752 participants
-0.1  (7.98) -1.3  (8.37)
32.Secondary Outcome
Title Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit
Hide Description Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 804 798
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
Pulse rate, Baseline Number Analyzed 804 participants 798 participants
73.2  (9.64) 73.7  (10.32)
Pulse rate, On-Therapy Number Analyzed 745 participants 751 participants
0.9  (8.24) 1.3  (8.66)
Pulse rate, Test of Cure Number Analyzed 732 participants 752 participants
1.8  (9.74) 1.7  (9.95)
33.Secondary Outcome
Title Change From Baseline in Body Temperature
Hide Description Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time Frame Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 804 798
Mean (Standard Deviation)
Unit of Measure: Celsius
Temperature, Baseline Number Analyzed 804 participants 798 participants
36.61  (0.346) 36.63  (0.317)
Temperature, On-Therapy Number Analyzed 744 participants 751 participants
-0.01  (0.334) -0.01  (0.372)
Temperature, Test of Cure Number Analyzed 732 participants 752 participants
-0.01  (0.349) -0.04  (0.351)
34.Secondary Outcome
Title Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
Hide Description Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles <=450, >450 to <=480, >480 to <=500 millisecond (msec) are the values at baseline. The category titles <= 30, 31-60, >60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented.
Time Frame Up to Day 31
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 791 784
Measure Type: Count of Participants
Unit of Measure: Participants
<= 450 msec Number Analyzed 746 participants 743 participants
<=30 msec
675
  90.5%
700
  94.2%
31-60 msec
23
   3.1%
12
   1.6%
>60 msec
1
   0.1%
0
   0.0%
Missing
47
   6.3%
31
   4.2%
>450 to <=480 msec Number Analyzed 45 participants 40 participants
<=30 msec
40
  88.9%
37
  92.5%
31-60 msec
2
   4.4%
0
   0.0%
>60 msec
0
   0.0%
0
   0.0%
Missing
3
   6.7%
3
   7.5%
>480 to <=500 msec Number Analyzed 0 participants 1 participants
<=30 msec
1
 100.0%
31-60 msec
0
   0.0%
>60 msec
0
   0.0%
Missing
0
   0.0%
35.Secondary Outcome
Title Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline
Hide Description Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles <=450 msec, >450 msec to <=480 msec are the values at baseline. The category titles <= 30, 31-60, >60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented.
Time Frame Up to Day 31
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description:
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
Overall Number of Participants Analyzed 791 784
Measure Type: Count of Participants
Unit of Measure: Participants
<= 450 msec Number Analyzed 783 participants 779 participants
<=30 msec
721
  92.1%
742
  95.3%
31-60 msec
12
   1.5%
4
   0.5%
>60 msec
0
   0.0%
0
   0.0%
Missing
50
   6.4%
33
   4.2%
>450 to <=480 msec Number Analyzed 8 participants 5 participants
<=30 msec
8
 100.0%
4
  80.0%
31-60 msec
0
   0.0%
0
   0.0%
>60 msec
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
  20.0%
Time Frame All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Adverse Event Reporting Description Safety population included all randomized participants who receive at least 1 dose of study treatment.
 
Arm/Group Title Gepotidacin Nitrofurantoin
Hide Arm/Group Description Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water. Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
All-Cause Mortality
Gepotidacin Nitrofurantoin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/804 (0.00%)      0/798 (0.00%)    
Hide Serious Adverse Events
Gepotidacin Nitrofurantoin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/804 (0.62%)      5/798 (0.63%)    
Cardiac disorders     
Atrial fribrillation  1  1/804 (0.12%)  1 0/798 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/804 (0.12%)  1 0/798 (0.00%)  0
Gastroesophageal reflux disease  1  1/804 (0.12%)  1 0/798 (0.00%)  0
Pancreatitis  1  0/804 (0.00%)  0 1/798 (0.13%)  1
Infections and infestations     
COVID-19  1  2/804 (0.25%)  2 0/798 (0.00%)  0
Pyelonephritis acute  1  0/804 (0.00%)  0 2/798 (0.25%)  2
Urosepsis  1  0/804 (0.00%)  0 1/798 (0.13%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/804 (0.00%)  0 1/798 (0.13%)  1
1
Term from vocabulary, 25.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Gepotidacin Nitrofurantoin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   235/804 (29.23%)      119/798 (14.91%)    
Gastrointestinal disorders     
Diarrhoea  1  147/804 (18.28%)  166 24/798 (3.01%)  25
Nausea  1  65/804 (8.08%)  66 35/798 (4.39%)  36
Flatulence  1  28/804 (3.48%)  29 4/798 (0.50%)  4
Faeces soft  1  23/804 (2.86%)  30 4/798 (0.50%)  4
Vomiting  1  18/804 (2.24%)  18 7/798 (0.88%)  7
Abdominal pain  1  12/804 (1.49%)  12 7/798 (0.88%)  8
Abdominal discomfort  1  9/804 (1.12%)  9 4/798 (0.50%)  5
General disorders     
Fatigue  1  3/804 (0.37%)  3 8/798 (1.00%)  8
Infections and infestations     
Urinary tract infection  1  11/804 (1.37%)  11 15/798 (1.88%)  15
Fungal infection  1  9/804 (1.12%)  9 10/798 (1.25%)  10
COVID-19  1  9/804 (1.12%)  9 5/798 (0.63%)  6
Nervous system disorders     
Headache  1  21/804 (2.61%)  23 22/798 (2.76%)  27
Dizziness  1  18/804 (2.24%)  18 11/798 (1.38%)  12
1
Term from vocabulary, 25.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04187144    
Other Study ID Numbers: 212390
2020-000553-27 ( EudraCT Number )
First Submitted: December 3, 2019
First Posted: December 5, 2019
Results First Submitted: May 29, 2023
Results First Posted: July 18, 2023
Last Update Posted: July 18, 2023