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Integral-1: Cefepime/nacubactam or aztreonam/nacubactam vs imipenem/cilastatin in complicated urinary tract infection or acute uncomplicated pyelonephritis
jRCT2031230075Phase 3Completed
- Sponsor
- Meiji Seika Pharma Co., Ltd.
- Start
- May 2023
- Modality
- Small Molecules, Irreversible Covalent Inhibitors → Covalent Small Molecules → Small Molecules
01
Overview
Phase 3, randomised, double-blind trial of cefepime + nacubactam, aztreonam + nacubactam and imipenem + cilastatin in complicated urinary tract infection (cUTI) and acute pyelonephritis (3 arms), sponsored by Meiji Seika Pharma Co., Ltd. Primary endpoint: Composite clinical and microbiological success at test-of-cure (TOC) in the m-MITT population. Started May 2023; status: completed.
02
Drugs
cefepime + nacubactamaztreonam + nacubactamimipenem + cilastatin
03
Conditions
complicated urinary tract infection (cUTI)acute pyelonephritis
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