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Phase 3 randomized single-blind study of cefepime + nacubactam or aztreonam + nacubactam versus best available therapy for carbapenem-resistant Enterobacterales infections

MOH_2023-03-01_012384Phase 3Recruiting

Sponsor
Meiji Seika Pharma Co., Ltd.
Start
Feb 2023
Modality
Reversible Covalent Inhibitors → Covalent Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
Countries
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Overview

Phase 3, randomised, single-blind trial of Nacubactam, cefepime and aztreonam in Enterobacterales infection, complicated urinary tract infection (cUTI), acute pyelonephritis and 3 more (3 arms), sponsored by Meiji Seika Pharma Co., Ltd. Primary endpoints: Overall treatment success by composite assessment across infection types and Safety of intravenous cefepime + nacubactam and aztreonam + nacubactam. Started Feb 2023; status: recruiting.

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Drugs

Nacubactamcefepimeaztreonam
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Conditions

Enterobacterales infectioncomplicated urinary tract infection (cUTI)acute pyelonephritishospital-acquired pneumonia (HAP)ventilator-associated pneumonia (VAP)

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