NCT03630081

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

A Phase III, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-Tazobactam vs. Meropenem Followed by Optional Oral Therapy in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,004 (estimated)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Complicated Urinary Tract Infection
• Acute Pyelonephritis

Interventions

Type	Name	Description
DRUG	WCK 4282 (FEP-TAZ) 4 g	WCK 4282 (FEP-TAZ) 4 g \[2 g FEP and 2 g TAZ\] IV q8h, infused over 90 min
DRUG	Meropenem	1 g IV q8h, infused over 45 min
DRUG	ciprofloxacin 500 mg Optional Oral Switch	ciprofloxacin 500 mg PO q12h
OTHER	Infusion of normal saline	Infusion of normal saline over 45 min

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2018-08-14
• Last updated: 2023-07-17

Regulatory

• FDA-regulated drug study