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

NCT ID: NCT05545137

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-29
• Study Completion Date: 2024-02-20

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

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.

Conditions

Uncomplicated Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Pivmecillinam hydrochloride tablets

Intervention Type: DRUG

400mg tablet

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.

Group Type: ACTIVE_COMPARATOR

Fosfomycin Tromethamine Granules

Intervention Type: DRUG

3g/pack

Interventions

Pivmecillinam hydrochloride tablets

400mg tablet

Intervention Type: DRUG

Fosfomycin Tromethamine Granules

3g/pack

Intervention Type: DRUG

Other Intervention Names

Selexid®; Monurol®

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Benova (Tianjin) Innovative medicine Research Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiangdong Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Beijing hospital

Beijing, Beijing Municipality, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, China

The second hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Wuhan Central Hospital

Wuhan, Hubei, China

Xiangya Humanity Rehabilitation hospital

Changsha, Hunan, China

Loudi Central Hospital

Loudi, Hunan, China

Yueyang people's Hospital

Yueyang, Hunan, China

Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine

Nanjing, Jiangsu, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

CS1046

Identifier Type: -

Identifier Source: org_study_id