RecruitingPhase 3NCT06569056

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

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

578 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HRS-8427, a drug called HRS-8427 placebo, and others for people with complicated urinary tract infection(cuti), including acute pyelonephritis(ap). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-8427

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

DRUGImipenem and Cilastatin Sodium

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

DRUGHRS-8427 placebo

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

DRUGImipenem 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

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NCT06569056