NCT05545137

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Benova (Tianjin) Innovative medicine Research Co., Ltd. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Pivmecillinam hydrochloride tablets	400mg tablet
DRUG	Fosfomycin Tromethamine Granules	3g/pack

Timeline

• Start date: 2022-09-29
• Primary completion: 2024-02-05
• Completion: 2024-02-20
• First posted: 2022-09-19
• Last updated: 2024-04-17

Locations

10 sites across 1 country: China