Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Phase 3 Unknown 1004 enrolled Wockhardt

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2024-01
Primary completion: 2026-01
Completion: 2026-02

Publications

Isler B, Harris P, Stewart AG, Paterson DL. An update on cefepime and its future role in combination with novel beta-lactamase inhibitors for MDR Enterobacterales and Pseudomonas aeruginosa. J Antimicrob Chemother. 2021 Feb 11;76(3):550-560. doi: 10.1093/jac/dkaa511.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cefepime	Small molecule	2 g	Intravenous
Comparator	Meropenem	Small molecule	1 g	Intravenous
Subject	Tazobactam	Small molecule	2 g	Intravenous
Background	Ciprofloxacin	Small molecule	500 mg	Oral

Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Summary

Timeline

Publications

Drugs

Indications