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Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05545137
Recruitment Status : Completed
First Posted : September 19, 2022
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Greenpine Pharma Group Co., ltd. ( Benova (Tianjin) Innovative medicine Research Co., Ltd. )

Brief Summary:
the purpose of this study is to evaluate the efficacy and safety of pivmecillinam hydrochloride tablets in the treatment of uncomplicated urinary tract infection in China

Condition or disease Intervention/treatment Phase
Uncomplicated Urinary Tract Infection Drug: Pivmecillinam hydrochloride tablets Drug: Fosfomycin Tromethamine Granules Phase 3

Detailed Description:

Screening period (D -3 to D -1): complete screening examinations will be performed after the subject signs the informed consent

Dosing Treatment Period (D 1 to D 5): subjects who met the inclusion criteria and did not meet the exclusion criteria were randomized. Refer to the randomization protocol for specific randomization process.

Safety check (D 5+1): perform on-site visit after 15 doses (D 5+1)

Post-treatment follow-up assessments ((D 12±2) and (D 21+7)): subjects returned to the study site for on-site follow-up on Day 12±2 and Day 21+7.

Urine bacterial culture and minimal inhibitory concentration (MIC) test: urine bacterial culture is required for subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pivmecillinam Hydrochloride Tablets Versus Fosfomycin Tromethamine Granules for Uncomplicated Urinary Tract Infection in Women -A Randomized, Double-blind, Double Simulation, Positive Drug Parallel-controlled, Multi Center Phase III Clinical Trial in China
Actual Study Start Date : September 29, 2022
Actual Primary Completion Date : February 5, 2024
Actual Study Completion Date : February 20, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pivmecillinam hydrochloride tablets treatment group

participants received Pivmecillinam Hydrochloride Tablets + Fosfomycin Tromethamine Granules Simulant.

Pivmecillinam Hydrochloride Tablets:oral,One tablets each time,3 times a day for five days.

Fosfomycin Tromethamine Granules Simulant :oral, 1 pack, only once for the entire course of treatment

Drug: Pivmecillinam hydrochloride tablets
400mg tablet
Other Name: Selexid®

Active Comparator: Fosfomycin Tromethamine Granules treatment group

participants received Fosfomycin Tromethamine Granules + Pivmecillinam Hydrochloride Tablets Simulant

Fosfomycin Tromethamine Granules:oral, 1 pack, only once for the entire course of treatment.

Pivmecillinam Hydrochloride Tablets Simulant :oral,One tablets each time,3 times a day for five days.

Drug: Fosfomycin Tromethamine Granules
3g/pack
Other Name: Monurol®




Primary Outcome Measures :
  1. Change in urinary tract infection symptom score [ Time Frame: From Baseline to Day 12±2 ]

    The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms).

    Change = (Day 12±2 Score - Baseline Score)


  2. Urine white blood cell count [ Time Frame: Day 12±2 ]
    Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.


Secondary Outcome Measures :
  1. Urine culture pathogen count at visit [ Time Frame: Day 12±2 ]
    The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to< 10^3 CFU(Colony-Forming Unit)/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).

  2. Change in urinary tract infection symptom score [ Time Frame: From Baseline to Day 5+1 ]

    The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, Urinary pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms).

    Change = (Day 12±2 Score - Baseline Score)


  3. Urine white blood cell count [ Time Frame: Day 5+1 ]
    Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.

  4. Urine culture pathogen count at visit [ Time Frame: Day 5+1 ]
    The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to<10^3 CFU/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).

  5. Change in urinary tract infection symptom score [ Time Frame: From Baseline to Day 21+7 ]

    The Urinary Tract Infection Symptom Score is a validated, self-reported tool to assess the severity of frequency, urgency, Urinary pain, dysuria, and may range from 0 (no symptoms) to 12 (worst symptoms).

    Change = (Day 12±2 Score - Baseline Score)


  6. Urine white blood cell count [ Time Frame: Day 21+7 ]
    Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.

  7. Urine culture pathogen count at visit [ Time Frame: Day 21+7 ]
    The urine culture pathogenic bacteria count at the visit was defined as: the urine culture pathogen (baseline pathogen) at enrollment was cleared at the visit or the bacterial count was reduced to<10^3 CFU/ml. The judgment results were: Yes, No, and could not be judged (could not be judged due to lack of culture results).

  8. Safety variables [ Time Frame: Day 5+1,Day 12±2,Day 21+7 ]
    Safety variables: adverse events reported by the patient at the visit or occurred during the trial.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female patients over 18 years of age with uncomplicated urinary tract infection ;
  2. Within 72 hours prior to study entry, the following symptoms or signs occurred: frequency of urine, urgency, dysuria (including suprapubic pain, pain or burning sensation on urination), dysuria, and symptom score ≥ 2 points;
  3. Urinalysis showed leukocyturia, i.e.,white blood cells≥ 10/μl on non-centrifuged urinalysis and white blood cell count greater than the upper limit of normal at the study site or white blood cells>5 /HP(high-power) on microscopic examination of urine sediment;
  4. Those who have no childbearing plan within the past 6 months (women of childbearing potential have a negative urine pregnancy test result at screening or within 72 hours before starting the trial) and agree to use effective non-drug contraception during the study;
  5. Subjects who agree to participate in this clinical trial and sign a written informed consent form (ICF);

Exclusion Criteria:

  1. Patients with acute or chronic upper urinary tract infection (eg, temperature > 38 °C, chills, or costovertebral angle pain, etc.);
  2. Other factors predisposing to urinary tract infection, including patients with known structural or functional abnormalities of the urinary tract such as urinary calculi;
  3. Patients with indwelling catheterization or urinary incontinence;
  4. Patients who have taken drugs for treatment of urinary tract infection or antibiotics for other diseases within 48 hours prior to dosing are excluded if the half-life of antibiotics taken by the subject is long and cannot be basically cleared before dosing as judged by the investigator, even if they have not taken any antibiotics within 48 hours prior to randomization;
  5. Have taken probenecid, metoclopramide, methotrexate, aspirin, or other antimicrobial agents within 48 hours prior to dosing;
  6. Have taken valproic acid or valproic acid-releasing drugs (including sodium valproate, sodium divalproex, etc.) within 48 hours prior to dosing;
  7. Previous or current STDs;
  8. Previous diabetes mellitus with unregulated treatment showing abnormal blood glucose ;
  9. Patients allergic (including lactose intolerance) to penicillins, pivmecillinam, mecillinam, cephalosporins, fosfomycin tromethamine, or other components of the study drug;
  10. Patients suspected to be unable to comply with the protocol (e.g., alcoholism, drug dependence, or poor mental status);
  11. Patients have been enrolled in this trial;
  12. Those who have participated in other drug interventional clinical trials or are participating in other clinical trials within 3 months prior to screening;
  13. Patients who have taken study drug within the past 3 months;
  14. Pregnant, lactating women, patients who are pregnant during the study or have a fertility plan within 3 months after the end of the trial;
  15. Complaints of active gastric ulcer and episodes of hemorrhagic gastritis;
  16. Abnormal liver and kidney function tests (ALT, AST ≥ 1.5 times the upper limit of normal, or serum creatinine ≥ 1.5 × upper limit (ULN) or creatinine clearance ≤ 50 mL/min), or other diseases that affect the efficacy of the drug as judged by the investigator ;
  17. Those who are judged by the investigator to be ineligible for enrollment by clinical laboratory tests, electrocardiograms, urinary ultrasound, etc.;
  18. Other reasons for inappropriate participation in the trial in the opinion of the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05545137


Locations
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China, Beijing
Beijing hospital
Beijing, Beijing, China, 100000
China, Guangdong
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
China, Guangxi
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China, 530000
China, Hebei
The second hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
China, Hubei
Wuhan Central Hospital
Wuhan, Hubei, China, 430000
China, Hunan
Xiangya Humanity Rehabilitation hospital
Changsha, Hunan, China, 410000
Loudi Central Hospital
Loudi, Hunan, China, 417000
Yueyang people's Hospital
Yueyang, Hunan, China, 414000
China, Jiangsu
Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine
Nanjing, Jiangsu, China, 210000
China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250000
Sponsors and Collaborators
Benova (Tianjin) Innovative medicine Research Co., Ltd.
Investigators
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Principal Investigator: Xiangdong Yang, PhD Qilu Hospital of Shandong University
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Responsible Party: Benova (Tianjin) Innovative medicine Research Co., Ltd.
ClinicalTrials.gov Identifier: NCT05545137    
Other Study ID Numbers: CS1046
First Posted: September 19, 2022    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Fosfomycin
Amdinocillin Pivoxil
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary