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Clinical Trial Summary

This is a Phase III, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-TAZ vs. meropenem in the treatment of hospitalized adults with cUTI or AP.


Clinical Trial Description

Approximately 1004 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 Subjects will be randomized in a 1:1 ratio according to an Interactive Response Technology (IRT) electronic system to receive either FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV every eight hours (q8h) or meropenem 1 g IV q8h. FEP-TAZ will be administered as 2 consecutive infusions of 2 g (1 g cefepime + 1 g tazobactam) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03630081
Study type Interventional
Source Wockhardt
Contact Manishkumar D Shah, PhD
Phone 91-22-26596000
Email Manish.Shah@wockhardt.com
Status Not yet recruiting
Phase Phase 3
Start date January 2024
Completion date February 2026

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