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Phase 3 study of cefepime/nacubactam and aztreonam/nacubactam versus best available therapy for carbapenem-resistant Enterobacterales infections
2021-001396-16Phase 3Active
- Sponsor
- Meiji Seika Pharma Co., Ltd.
- Start
- Jan 2023
- Modality
- Reversible Covalent Inhibitors → Covalent Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
- Countries
- 1
01
Overview
Phase 3, randomised, single-blind trial of Nacubactam, cefepime and aztreonam in complicated urinary tract infection (cUTI), acute pyelonephritis, hospital-acquired pneumonia (HAP) and 3 more (3 arms), sponsored by Meiji Seika Pharma Co., Ltd. Primary endpoint: Overall treatment success at test of cure across all infection types. Started Jan 2023; status: active.
02
Drugs
Nacubactamcefepimeaztreonam
03
Conditions
complicated urinary tract infection (cUTI)acute pyelonephritishospital-acquired pneumonia (HAP)ventilator-associated pneumonia (VAP)Intra-abdominal infection (IAI)
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