clinical trial · NCT05887908
Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
Meiji Seika Pharma Co., Ltd.·phase3·completed·n = 614
Complicated Urinary Tract InfectionAcute PyelonephritiscUTIAPco-administration of cefepime and nacubactamco-administration of aztreonam and nacubactamimipenem/cilastatin
brief summary
Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).
started
May 23, 2023
primary completion
Nov 22, 2024
completion
Nov 26, 2024
last updated
Dec 24, 2025
official title
A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis, in Adults
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol