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

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

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

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100000
        • Completed
        • Beijing Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
        • Contact:
        • Principal Investigator:
          • Abai Xu
        • Sub-Investigator:
          • Peng Xu
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Completed
        • Guangxi Zhuang Autonomous Region People's Hospital
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Completed
        • The Second Hospital of Hebei Medical University
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Wuhan Central Hospital
        • Contact:
          • kerui li
        • Principal Investigator:
          • yonglian guo, md
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Xiangya Humanity Rehabilitation hospital
        • Principal Investigator:
          • bin huang
      • Loudi, Hunan, China, 417000
        • Completed
        • Loudi Central Hospital
      • Yueyang, Hunan, China, 414000
        • Completed
        • Yueyang People's Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Completed
        • Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine
    • Shandong
      • Jinan, Shandong, China, 250000
        • Completed
        • Qilu Hospital of Shandong University
      • Yantai, Shandong, China, 264000
        • Withdrawn
        • Yantai Yuhuangding Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

400mg tablet
Other Names:
  • 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.

3g/pack
Other Names:
  • Monurol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

From Baseline to Day 12±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.
Day 12±2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 12±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)

From Baseline to Day 5+1
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.
Day 5+1
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).
Day 5+1
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)

From Baseline to Day 21+7
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.
Day 21+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).
Day 21+7
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.
Day 5+1,Day 12±2,Day 21+7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xiangdong Yang, PhD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uncomplicated Urinary Tract Infection

Clinical Trials on Pivmecillinam hydrochloride tablets

3
Subscribe