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Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections

NCT05060419 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-09-29

No results posted yet for this study

Summary

Phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis.Treatment duration for each cohort was 7 to 14 days. Patients were not permitted to switch to oral therapy.

Conditions

  • Complicated Urinary Tract Infection
  • Acute Pyelonephritis

Interventions

DRUG

Meropenem- FL058

Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h

DRUG

Piperacillin -tazobactam

Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h

DRUG

Saline

180min

DRUG

Saline

30min

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Huang Haihui, Professor · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2022-04-29
Completion
2022-08-31

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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 NCT05060419 on ClinicalTrials.gov