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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,004

Participants

Timeline

Start Date

January 31, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

February 28, 2026

Conditions
Complicated Urinary Tract InfectionAcute Pyelonephritis
Interventions
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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Wockhardt

INDUSTRY