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

NCT03630081 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1004

Last updated 2023-07-17

No results posted yet for this study

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.

Conditions

  • Complicated Urinary Tract Infection
  • Acute 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 & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Manishkumar D Shah, PhD · Wockhardt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2026-01-31
Completion
2026-02-28
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03630081 on ClinicalTrials.gov