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OP0595-5 cUTI/AP trial
2024-515463-55-00Phase 3Completed
- Sponsor
- Meiji Seika Pharma Co., Ltd.
- Start
- Aug 2024
- Modality
- Reversible Covalent Inhibitors → Covalent Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
- Countries
- 9
01
Overview
Phase 3, randomised, double-blind trial in complicated urinary tract infection (cUTI), acute pyelonephritis and Bacteremia comparing Cefepime + Nacubactam, Aztreonam + Nacubactam and Imipenem + Cilastatin (active control) (3 arms). Primary endpoint: Composite clinical and microbiological success at Test of Cure (TOC) in mMITT population. Started Aug 2024; status: completed.
02
Drugs
Nacubactamcefepimeaztreonamimipenem + cilastatin
03
Conditions
complicated urinary tract infection (cUTI)acute pyelonephritisBacteremia
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