Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison Wi… (NCT05204368) | Clinical Trial Compass
UnknownPhase 3
Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40)
United States780 participantsStarted 2023-03-30
Plain-language summary
This is A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/Funobactam in Comparison with Meropenem in Hospitalized Adults with Complicated Urinary Tract Infections, including Acute Pyelonephritis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients willing and able to provide written informed consent.
✓. Willing and able to comply with all study assessments and adhere to the protocol schedule.
✓. Hospitalized or requiring hospitalization for cUTI or AP in male or female patients ≥18 years on the day of signing informed consent.
✓. Requiring treatment with IV antibiotic therapy.
✓. Evidence of AP or cUTI
✓. Having at least 1 of the following complicated factors for cUTI (not required for AP):
✓. Indwelling catheter of the urinary tract.
✓. Urinary retention.
Exclusion criteria
✕. Patients with any of the following conditions:
✕. Suspected or confirmed perinephric abscess
✕. Suspected or confirmed renal corticomedullary abscess
✕. Suspected or confirmed acute or chronic bacterial prostatitis, orchitis, or epididymitis, as determined by history and/or physical examination
✕. Known polycystic kidney disease or only 1 functional kidney