Overview

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.