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

NCT05545137 | Completed Phase 3

• 1 other identifier: CS1046
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 10

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

Conditions

Uncomplicated Urinary Tract Infection

Outcome Measures

Primary Outcomes (2)

• Change in urinary tract infection symptom score

  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

  Defined as whether the subject 's white blood cell count returned to normal. The result was yes or no.

  Day 12±2

Secondary Outcomes (8)

• Urine culture pathogen count at visit

  Day 12±2

• Change in urinary tract infection symptom score

  From Baseline to Day 5+1

• Urine white blood cell count

  Day 5+1

• Urine culture pathogen count at visit

  Day 5+1

• Change in urinary tract infection symptom score

  From Baseline to Day 21+7

Study Arms (2)

Pivmecillinam hydrochloride tablets treatment group

EXPERIMENTAL

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

Fosfomycin Tromethamine Granules treatment group

ACTIVE COMPARATOR

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

Interventions

Pivmecillinam hydrochloride tablets DRUG

400mg tablet

Also known as: Selexid®

Pivmecillinam hydrochloride tablets treatment group

Fosfomycin Tromethamine Granules DRUG

3g/pack

Also known as: Monurol®

Fosfomycin Tromethamine Granules treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients over 18 years of age with uncomplicated urinary tract infection ;
• 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;
• 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;
• 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;
• Subjects who agree to participate in this clinical trial and sign a written informed consent form (ICF);

You may not qualify if:

• Patients with acute or chronic upper urinary tract infection (eg, temperature \> 38 °C, chills, or costovertebral angle pain, etc.);
• Other factors predisposing to urinary tract infection, including patients with known structural or functional abnormalities of the urinary tract such as urinary calculi;
• Patients with indwelling catheterization or urinary incontinence;
• 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;
• Have taken probenecid, metoclopramide, methotrexate, aspirin, or other antimicrobial agents within 48 hours prior to dosing;
• Have taken valproic acid or valproic acid-releasing drugs (including sodium valproate, sodium divalproex, etc.) within 48 hours prior to dosing;
• Previous or current STDs;
• Previous diabetes mellitus with unregulated treatment showing abnormal blood glucose ;
• Patients allergic (including lactose intolerance) to penicillins, pivmecillinam, mecillinam, cephalosporins, fosfomycin tromethamine, or other components of the study drug;
• Patients suspected to be unable to comply with the protocol (e.g., alcoholism, drug dependence, or poor mental status);
• Patients have been enrolled in this trial;
• Those who have participated in other drug interventional clinical trials or are participating in other clinical trials within 3 months prior to screening;
• Patients who have taken study drug within the past 3 months;
• Pregnant, lactating women, patients who are pregnant during the study or have a fertility plan within 3 months after the end of the trial;
• Complaints of active gastric ulcer and episodes of hemorrhagic gastritis;

Sponsors & Collaborators

• Benova (Tianjin) Innovative medicine Research Co., Ltd.: lead

Study Sites (10)

Beijing hospital

Beijing, Beijing Municipality, 100000, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, 530000, China

Location

The second hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Wuhan Central Hospital

Wuhan, Hubei, 430000, China

Location

Xiangya Humanity Rehabilitation hospital

Changsha, Hunan, 410000, China

Location

Loudi Central Hospital

Loudi, Hunan, 417000, China

Location

Yueyang people's Hospital

Yueyang, Hunan, 414000, China

Location

Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine

Nanjing, Jiangsu, 210000, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

MeSH Terms

Interventions

Amdinocillin Pivoxil; Fosfomycin

Intervention Hierarchy (Ancestors)

Amdinocillin; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds

Study Officials

• Xiangdong Yang, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 19, 2022
• Study Start: September 29, 2022
• Primary Completion: February 5, 2024
• Study Completion: February 20, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)