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

NCT06569056 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 578

Last updated 2025-01-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06569056 on ClinicalTrials.gov