UnknownPhase 3

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

1,004 participantsStarted 2024-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Have at least TWO of the following new-onset or worsening symptoms or signs:
✓. Have at least ONE complicating factor

Exclusion criteria

✕. Known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy.
✕. Receipt of potentially-effective systemic antibacterial therapy within 72 h prior to randomization
✕. Rapidly progressive or terminal illness with a high risk of mortality due to any cause, including but not limited to acute hepatic failure, respiratory failure, or septic shock, such that the subject is unlikely to survive the study period

What they're measuring

Percentage of subjects with overall success at Day 5

Timeframe: Day 5

Percentage of subjects with overall success at Test-of-Cure

Timeframe: Test Of Cure Visit (Day 17 ± 2 days)

Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)

Timeframe: Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)

Trial details

NCT IDNCT03630081

SponsorWockhardt

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01

Contact for this trial

Manishkumar D Shah, PhD

91-22-26596000 Manish.Shah@wockhardt.com

View on ClinicalTrials.gov More Complicated Urinary Tract Infection trials