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RECRUITING
NCT06569056
PHASE3

A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

578

Start Date

2024-09-25

Completion Date

2025-11

Last Updated

2025-01-22

Healthy Volunteers

No

Interventions

DRUG

HRS-8427

Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses

DRUG

Imipenem and Cilastatin Sodium

Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses

DRUG

HRS-8427 placebo

Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses

DRUG

Imipenem and Cilastatin Sodium placebo

Dosing frequency: for 7-14 days; dose adjustments of subjects with reduced function include reduced doses

Locations (1)

Shanghai Huashan Hospital

Shanghai, Shanghai Municipality, China