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Clinical Trial Summary

This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP. Approximately 528 hospitalized adult subjects (≥ 18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria. The total duration of treatment with study drug is 7 to 10 days. Each subject must remain hospitalized during the study drug treatment period; no outpatient parenteral antibiotic therapy is allowed.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04979806
Study type Interventional
Source Wockhardt
Contact Medical Monitor, MD
Phone 847-894-7392
Email clinicaltrials@mgp-online.com
Status Recruiting
Phase Phase 3
Start date August 28, 2022
Completion date May 2024

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