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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benova (Tianjin) Innovative medicine Research Co., Ltd.
• Treatments: Amdinocillin Pivoxil; Fosfomycin

Criteria

Inclusion Criteria:

1. Female patients aged 18 to 70(inclusive) years with uncomplicated urinary tract infection ;

2. At least 2 of the following symptoms or signs within 72 hours prior to study entry:

frequent urgency, dysuria (including suprapubic pain, pain or burning sensation), dysuria;

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 who complained of frequent symptoms of diarrhea at screening (more than 3 episodes of diarrhea in the past 1 month);

4. Patients with indwelling catheterization or urinary incontinence;

5. 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;

6. Have taken probenecid, metoclopramide, methotrexate, aspirin, or other antimicrobial agents within 48 hours prior to dosing;

7. Have taken valproic acid or valproic acid-releasing drugs (including sodium valproate, sodium divalproex, etc.) within 48 hours prior to dosing;

8. Patients with immunosuppression, neurological disorders, or venereal diseases;

9. Patients with a previous diagnosis of diabetes mellitus, nephropathy or confirmed by laboratory tests;

10. Patients allergic (including lactose intolerance) to penicillins, pivmecillinam, mecillinam, cephalosporins, fosfomycin tromethamine, or other components of the study drug;

11. Patients suspected to be unable to comply with the protocol (e.g., alcoholism, drug dependence, or poor mental status);

12. Patients have been enrolled in this trial;

13. Those who have participated in other drug interventional clinical trials or are participating in other clinical trials within 3 months prior to screening;

14. Patients who have taken study drug within the past 3 months;

15. Pregnant, lactating women, patients who are pregnant during the study or have a fertility plan within 3 months after the end of the trial;

16. Complaints of active gastric ulcer and episodes of hemorrhagic gastritis;

17. History of congestive heart failure, uncontrolled hypertension (resting sitting systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg on 2 or more consecutive occasions), uncontrolled coronary heart disease, or arrhythmia;

18. History of blood diseases (neutrophil count ≤ 1.5 × 10^9/L; platelets ≤ 75 × 10^9/L; blood chemistry criteria: alanine transferase, aspartate transferase, alkaline phosphatase, gamma-glutamyl transpeptidase, any of which is ≥ 2.5 × upper limit (ULN); serum total bilirubin ≥ 1.5 × upper limit (ULN); serum creatinine ≥ 1.5 × upper limit (ULN) or creatinine clearance ≤ 50 mL/min) and liver, neuropathy, psychosis, kidney that affect the efficacy of the drug as judged by the investigator;

19. Those who are judged by the investigator to be ineligible for enrollment by clinical laboratory tests, electrocardiograms, urinary ultrasound, etc.;

20. Other reasons for inappropriate participation in the trial in the opinion of the investigator.