NCT06569056

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 578 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-25
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2024-08-23
• Last updated: 2025-01-22

Locations

1 site across 1 country: China