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Phase 3 study of cefepime + nacubactam or aztreonam + nacubactam versus imipenem + cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis
2021-001441-12Phase 3Active
- Sponsor
- Meiji Seika Pharma Co., Ltd.
- Start
- Dec 2022
- Modality
- Small Molecules, Reversible Covalent Inhibitors → Covalent Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in complicated urinary tract infection (cUTI) and acute pyelonephritis comparing cefepime + nacubactam, aztreonam + nacubactam and imipenem + cilastatin (3 arms). Primary endpoint: Composite clinical and microbiological success at test of cure. Started Dec 2022; status: active.
02
Drugs
cefepimeNacubactamaztreonamimipenemcilastatin
03
Conditions
complicated urinary tract infection (cUTI)acute pyelonephritis
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