Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pye… (NCT04979806) | Clinical Trial Compass
CompletedPhase 3
Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
United States, Bulgaria530 participantsStarted 2022-08-28
Plain-language summary
This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP.
Approximately 528 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. The total duration of treatment with study drug is 7 to 10 days. Each subject must remain hospitalized during the study drug treatment period; no outpatient parenteral antibiotic therapy is allowed.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female ≥ 18 years of age
✓. Provide a signed written informed consent prior to any study-specific procedures
✓. Meet the clinical criteria for either cUTI or AP
✓. Requires hospitalization to manage the cUTI or AP
✓. Agrees to use effective methods of contraception
Exclusion criteria
✕. Known or suspected disease that may confound the assessment of efficacy.
✕. Receipt of more than 72 hours of prior antibiotic therapy except for those failing prior antibiotic therapy and/or having documented uropathogen resistant to the prior therapy.
✕. Rapidly progressive illness such that the subject is unlikely to survive the study period.
✕. Pregnant or breastfeeding women
✕. History of a seizure disorder requiring current treatment
What they're measuring
1
Percentage of subjects with overall success at Test-of-Cure
Timeframe: Test Of Cure Visit (Day 17 ± 2 days)
2
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)]