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Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40)

NCT05204368 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2023-02-16

No results posted yet for this study

Summary

This is A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/Funobactam in Comparison with Meropenem in Hospitalized Adults with Complicated Urinary Tract Infections, including Acute Pyelonephritis.

Conditions

  • Complicated Urinary Tract Infection Including Acute Pyelonephritis

Interventions

DRUG

Combination of Imipenem/Cilastatin and XNW4107

Imipenem/Cilastatin 500mg/500mg and XNW4107 250mg for injection

DRUG

Meropenem

Meropenem 1g for injection

Sponsors & Collaborators

  • Evopoint Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Jason Le · Evopoint Biosciences Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2025-06-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05204368 on ClinicalTrials.gov