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Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex (ATTACK)

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ClinicalTrials.gov Identifier: NCT03894046
Recruitment Status : Completed
First Posted : March 28, 2019
Results First Posted : February 1, 2023
Last Update Posted : February 1, 2023
Sponsor:
Information provided by (Responsible Party):
Entasis Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acinetobacter Baumannii-calcoaceticus Complex
Hospital-acquired Bacterial Pneumonia
Ventilator-associated Bacterial Pneumonia
Bacteremia
Colistin Resistant ABC
Interventions Drug: Sulbactam
Drug: Durlobactam
Drug: Colistin
Drug: Imipenem/Cilastatin 500 mg/500 mg
Enrollment 207
Recruitment Details  
Pre-assignment Details The total number of participants enrolled in the study was 207. However, two (2) patients were transferred from Part A to part B. These participants were analyzed at each arm until/ from the time point of transfer.
Arm/Group Title Part A - Group 1 Part A - Group 2 Part B - Group 3
Hide Arm/Group Description

Experimental.

1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h;

Control group.

2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.

Experimental.

Group 3: 1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.
Period Title: Overall Study
Started 92 89 26
Completed 69 61 20
Not Completed 23 28 6
Reason Not Completed
Protocol Violation             1             0             0
Adverse Event             0             1             0
Withdrawal by Subject             2             3             1
Death             15             21             4
No growth of ABC             2             1             0
Physician Decision             1             1             1
Prohibited concomitant medication             1             0             0
Transferred to other arm/group             1             1             0
Arm/Group Title Part A- Group 1 Part A - Group 2 Part B - Group 3 Total
Hide Arm/Group Description Experimental. Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h; Control Group (active comparator). Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. Experimental. Group 3: 1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h. Total of all reporting groups
Overall Number of Baseline Participants 92 89 26 207
Hide Baseline Analysis Population Description
Two (2) participants were transferred from Part A to part B. These participants were analyzed at each arm until/ from the time point of transfer. The number of participants is reported according to the initial Arm/group in which individual participant was assigned.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 89 participants 26 participants 207 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
43
  46.7%
37
  41.6%
18
  69.2%
98
  47.3%
>=65 years
49
  53.3%
52
  58.4%
8
  30.8%
109
  52.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 89 participants 26 participants 207 participants
63.4  (15.42) 66.9  (17.13) 56.2  (16.33) 59.8  (16.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 89 participants 26 participants 207 participants
Female
24
  26.1%
23
  25.8%
5
  19.2%
52
  25.1%
Male
68
  73.9%
66
  74.2%
21
  80.8%
155
  74.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 89 participants 26 participants 207 participants
American Indian or Alaska Native
5
   5.4%
2
   2.2%
0
   0.0%
7
   3.4%
Asian
33
  35.9%
44
  49.4%
3
  11.5%
80
  38.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   1.1%
0
   0.0%
1
   0.5%
White
48
  52.2%
41
  46.1%
23
  88.5%
112
  54.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
   6.5%
1
   1.1%
0
   0.0%
7
   3.4%
1.Primary Outcome
Title Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population
Hide Description The primary efficacy endpoint for the study is 28-day all-cause mortality in the CRABC m-MITT population in Part A.
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description

CRABC m-MITT (Carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex Microbiologically Modified Intent-to-Treat Population).

The CRABC m-MITT Population included patients who met m-MITT criteria and had a baseline ABC organism that was confirmed to be carbapenem-resistant (MIC of imipenem/meropenem ≥8 ug/mL) by the central laboratory or by the local laboratory.
Arm/Group Title Part A - Group 1 Part A - Group 2
Hide Arm/Group Description:

Experimental.

Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h;

Control group (active comparator).

Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.
Overall Number of Participants Analyzed 63 62
Measure Type: Count of Participants
Unit of Measure: Participants
12
  19.0%
20
  32.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A - Group 1, Part A - Group 2
Comments The non-inferiority assessment was based on the 2-sided 95% CIs computed using a continuity-corrected Z-statistic for the difference ([sulbactam-durlobactam + imipenem/cilastatin] - [colistin + imipenem/cilastatin]) in 28-day all-cause mortality rates between the treatment groups.
Type of Statistical Test Non-Inferiority
Comments

Non-inferiority was concluded if the upper limit of the 2-sided 95% CI was less than +20%.

Superiority was concluded if the upper limit of the 2-sided 95% CI was less than 0.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.2
Confidence Interval (2-Sided) 95%
-30 to 3.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title Proportion of Patients With Nephrotoxicity
Hide Description The primary safety endpoint for the study is nephrotoxicity, as measured by the Risk-Injury-Failure-Loss-End-stage renal disease (RIFLE) criteria, in the MITT population in Part A.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description

MITT (Modified Intent To Treat population containing all patients who received any amount of study drug).

Analysis of patients with nephrotoxicity as measured by RIFLE criteria at any post-baseline visit based on the Investigator's opinion for the Safety Population for Part A, excluding patients with chronic hemodialysis at baseline.
Arm/Group Title Part A - Group 1 Part A - Group 2
Hide Arm/Group Description:

Experimental.

Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h;

Control group (active comparator).

Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.
Overall Number of Participants Analyzed 91 85
Measure Type: Count of Participants
Unit of Measure: Participants
12
  13.2%
32
  37.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A - Group 1, Part A - Group 2
Comments Analysis of patients with nephrotoxicity as measured by RIFLE criteria at any post-baseline visit based on the Investigator's opinion for the Safety Population for Part A, excluding patients with chronic hemodialysis at baseline baseline.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments p-value was obtained based on a Chi-Square test for treatment group differences.
Method Chi-squared
Comments [Not Specified]
Time Frame Adverse event monitoring starts from the time the patient consents to the study until up to 30 days after treatment.
Adverse Event Reporting Description

A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug.

NOTE: Total Number of Participants at Risk includes participants who received at least one dose of the study treatment. This also applies to Serious and Other (Not Including Serious) Adverse Events described below.
 
Arm/Group Title Part A - Group 1 Part A - Group 2 Part B - Group 3
Hide Arm/Group Description

Experimental. Group 1 (experimental): 1.0 g sulbactam/1.0 g durlobactam IV infused over 3 hours every 6 hours (q6h) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h;

In total, 91 patients received any amount of study drug treatment in Part A - Group 1 and were considered the Safety Population for this group.

Control group (active comparator). Group 2 (control group): 2.5 mg/kg colistin IV infused over 30 minutes every 12 hours (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.

In total, 86 patients received any amount of study drug treatment in Part A - Group 2 - control group and were considered the Safety Population for this group.

Experimental. Group 3: 1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.

There were 28 patients who received any amount of study drug in Part B and were included in the Safety Population for Part B.
All-Cause Mortality
Part A - Group 1 Part A - Group 2 Part B - Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/91 (27.47%)      31/86 (36.05%)      4/28 (14.29%)    
Hide Serious Adverse Events
Part A - Group 1 Part A - Group 2 Part B - Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/91 (39.56%)      42/86 (48.84%)      9/28 (32.14%)    
Blood and lymphatic system disorders       
Anaemia † 1  0/91 (0.00%)  0 2/86 (2.33%)  3 0/28 (0.00%)  0
Agranulocytosis † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Neutropenia † 1  0/91 (0.00%)  0 0/86 (0.00%)  0 1/28 (3.57%)  1
Cardiac disorders       
Cardiac arrest † 1  2/91 (2.20%)  2 4/86 (4.65%)  4 1/28 (3.57%)  1
Acute myocardial infarction † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Arteriosclerosis coronary artery † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Atrial fibrillation † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Bradycardia † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Cardio-respiratory arrest † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Ventricular tachycardia † 1  0/91 (0.00%)  0 0/86 (0.00%)  0 1/28 (3.57%)  1
Congenital, familial and genetic disorders       
Tracheo-oesophageal fistula † 1  2/91 (2.20%)  2 0/86 (0.00%)  0 0/28 (0.00%)  0
Gastrointestinal disorders       
Gastrointestinal haemorrhage † 1  2/91 (2.20%)  2 1/86 (1.16%)  1 0/28 (0.00%)  0
Colitis ulcerative † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Duodenal ulcer perforation † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Gastrointestinal perforation † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Intestinal ischaemia † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Intestinal obstruction † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Intra-abdominal haemorrhage † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Thrombosis mesenteric vessel † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Ascites † 1  0/91 (0.00%)  0 0/86 (0.00%)  0 1/28 (3.57%)  1
Diverticulum intestinal haemorrhagic † 1  0/91 (0.00%)  0 0/86 (0.00%)  0 1/28 (3.57%)  1
General disorders       
Multiple organ dysfunction syndrome † 1  1/91 (1.10%)  1 4/86 (4.65%)  4 2/28 (7.14%)  2
Disease progression † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Hepatobiliary disorders       
Drug-induced liver injury † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Hepatic function abnormal † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 1/28 (3.57%)  1
Ischaemic hepatitis † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Primary biliary cholangitis † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Infections and infestations       
Septic shock † 1  7/91 (7.69%)  9 7/86 (8.14%)  7 0/28 (0.00%)  0
Pneumonia † 1  1/91 (1.10%)  1 4/86 (4.65%)  4 0/28 (0.00%)  0
Sepsis † 1  2/91 (2.20%)  2 3/86 (3.49%)  3 0/28 (0.00%)  0
Acinetobacter infection † 1  1/91 (1.10%)  1 1/86 (1.16%)  1 0/28 (0.00%)  0
Pneumonia bacterial † 1  1/91 (1.10%)  1 1/86 (1.16%)  1 0/28 (0.00%)  0
Pneumonia pseudomonal † 1  1/91 (1.10%)  1 1/86 (1.16%)  1 0/28 (0.00%)  0
Bacterial sepsis † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Cholecystitis infective † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Clostridium difficile colitis † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Coronavirus infection † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Encephalitis † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Klebsiella sepsis † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Mastoiditis † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Meningitis bacterial † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Peritonitis † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Pneumonia klebsiella † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Pseudomembranous colitis † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Pseudomonas infection † 1  0/91 (0.00%)  0 1/86 (1.16%)  2 0/28 (0.00%)  0
Staphylococcal bacteraemia † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 1/28 (3.57%)  1
Systemic candida † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Liver abscess † 1  0/91 (0.00%)  0 0/86 (0.00%)  0 1/28 (3.57%)  1
Lung infection † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Injury, poisoning and procedural complications       
Alcohol poisoning † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Chemical peritonitis † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Craniocerebral injury † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Post procedural haemorrhage † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Tracheostomy malfunction † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Weaning failure † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Investigations       
Liver function test abnormal † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant neoplasm progression † 1  1/91 (1.10%)  1 1/86 (1.16%)  1 0/28 (0.00%)  0
Metastases to central nervous system † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Metastases to lung † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Nervous system disorders       
Brain oedema † 1  2/91 (2.20%)  2 1/86 (1.16%)  1 0/28 (0.00%)  0
Seizure † 1  0/91 (0.00%)  0 3/86 (3.49%)  3 0/28 (0.00%)  0
Cerebral haemorrhage † 1  1/91 (1.10%)  2 1/86 (1.16%)  1 0/28 (0.00%)  0
Cerebrovascular accident † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Haemorrhage intracranial † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Ischaemic stroke † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury † 1  1/91 (1.10%)  1 2/86 (2.33%)  2 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome † 1  2/91 (2.20%)  2 2/86 (2.33%)  2 0/28 (0.00%)  0
Pulmonary embolism † 1  1/91 (1.10%)  1 2/86 (2.33%)  2 0/28 (0.00%)  0
Respiratory failure † 1  2/91 (2.20%)  2 1/86 (1.16%)  1 1/28 (3.57%)  1
Acute respiratory failure † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Bronchial obstruction † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Hypercapnia † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Pleural effusion † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 1/28 (3.57%)  1
Pneumonia aspiration † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Tracheomalacia † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Vascular disorders       
Deep vein thrombosis † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 0/28 (0.00%)  0
Peripheral artery thrombosis † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Shock † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 0/28 (0.00%)  0
Shock haemorrhagic † 1  1/91 (1.10%)  1 0/86 (0.00%)  0 1/28 (3.57%)  1
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A - Group 1 Part A - Group 2 Part B - Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/91 (52.75%)      53/86 (61.63%)      14/28 (50.00%)    
Blood and lymphatic system disorders       
Anaemia † 1  12/91 (13.19%)  18 11/86 (12.79%)  13 4/28 (14.29%)  4
Thrombocytopenia † 1  5/91 (5.49%)  5 1/86 (1.16%)  1 0/28 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea † 1  15/91 (16.48%)  16 9/86 (10.47%)  11 2/28 (7.14%)  2
Constipation † 1  5/91 (5.49%)  7 5/86 (5.81%)  6 0/28 (0.00%)  0
Nausea † 1  0/91 (0.00%)  0 2/86 (2.33%)  3 2/28 (7.14%)  2
General disorders       
Pyrexia † 1  9/91 (9.89%)  14 8/86 (9.30%)  11 1/28 (3.57%)  1
Infections and infestations       
Urinary tract infection † 1  7/91 (7.69%)  11 8/86 (9.30%)  9 1/28 (3.57%)  1
Tracheobronchitis † 1  5/91 (5.49%)  5 1/86 (1.16%)  1 0/28 (0.00%)  0
Investigations       
Blood creatinine increased † 1  2/91 (2.20%)  6 7/86 (8.14%)  10 3/28 (10.71%)  3
Blood alkaline phosphatase increased † 1  0/91 (0.00%)  0 1/86 (1.16%)  1 2/28 (7.14%)  2
Enterococcus test positive † 1  0/91 (0.00%)  0 0/86 (0.00%)  0 3/28 (10.71%)  3
Gamma-glutamyltransferase increased † 1  1/91 (1.10%)  2 2/86 (2.33%)  2 2/28 (7.14%)  2
Metabolism and nutrition disorders       
Hypokalaemia † 1  13/91 (14.29%)  21 9/86 (10.47%)  19 0/28 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury † 1  3/91 (3.30%)  3 9/86 (10.47%)  12 0/28 (0.00%)  0
Renal impairment † 1  0/91 (0.00%)  0 6/86 (6.98%)  9 1/28 (3.57%)  1
Skin and subcutaneous tissue disorders       
Decubitus ulcer † 1  5/91 (5.49%)  5 3/86 (3.49%)  3 4/28 (14.29%)  4
Vascular disorders       
Hypotension † 1  5/91 (5.49%)  5 5/86 (5.81%)  5 1/28 (3.57%)  1
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
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Name/Title: Dr. David Altarac - Chief Medical Officer
Organization: Entasis Therapeutics
Phone: +1 781 810 0120
EMail: david.altarac@entasistx.com
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Responsible Party: Entasis Therapeutics
ClinicalTrials.gov Identifier: NCT03894046    
Other Study ID Numbers: CS2514-2017-0004
First Submitted: March 27, 2019
First Posted: March 28, 2019
Results First Submitted: November 7, 2022
Results First Posted: February 1, 2023
Last Update Posted: February 1, 2023