A Multi-center, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase III Study to Evaluate the Efficacy and Safety of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the efficacy and safety of HRS-8427 in patients with complicated urinary tract infection, including acute pyelonephritis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Able and willing to provide a written informed consent before the study, fully understand the study and be able to complete the study according to the protocol;

• Male and female, ≥18 years;

• Judged by the investigator, clinical diagnosis with cUTI or AP, expectation that the patients will require hospitalization and initial treatment with intravenous antibiotics;

• Urine specimen with evidence of pyuria;

• Have urine culture specimen obtained within 48 hours prior to randomization;

• 48 hours before random, allowing a short course of antimicrobial drug treatment is less than 24 hours (random rate ≤25%)

• Women of childbearing potential must have a negative serum pregnancy test before first dose, must be non-lactating. Fertile female subjects or male subjects whose partner is a fertile female agree to use highly effective form of contraception, with no plan of birth, sperm/ovum donation from the time of signed ICF till 14 days after end of treatment.

Locations
Other Locations
China
Shanghai Huashan Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xiaopeng Wang
xiaopeng.wang@hengrui.com
+0518-81220121
Backup
Jing Xu
jing.xu.jx23@hengrui.com
+021-23511999
Time Frame
Start Date: 2024-09-25
Estimated Completion Date: 2025-11
Participants
Target number of participants: 578
Treatments
Experimental: HRS-8427; Imipenem and Cilastatin Sodium placebo
Active_comparator: Imipenem and Cilastatin Sodium; HRS-8427 placebo
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov