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Clinical trial

A Phase 3, Multi-Center, Randomized, Single-Blind Study to Assess the Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy in Adults With Complicated Urinary Tract Infection, Acute Uncomplicated Pyelonephritis, Hospital-Acquired Bacterial Pneumonia, Ventilator Associated Bacterial Pneumonia, and Complicated Intra-Abdominal Infection Due to Carbapenem Resistant Enterobacterales

NCT05905055 is registered in ClinicalTrials.gov with Meiji Seika Pharma Co., Ltd. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3, Multi-Center, Randomized, Single-Blind Study to Assess the Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy in Adults With Complicated Urinary Tract Infection, Acute Uncomplicated Pyelonephritis, Hospital-Acquired Bacterial Pneumonia, Ventilator Associated Bacterial Pneumonia, and Complicated Intra-Abdominal Infection Due to Carbapenem Resistant Enterobacterales
Lead sponsor
Meiji Seika Pharma Co., Ltd.
Phase
Phase 3
Overall status
Completed
Start date
September 22, 2023
Completion date
September 1, 2025
Enrollment
126 (actual)
Sites
54

Conditions

As the registry lists them; a condition with its own page is linked.

acute pyelonephritis, complicated intra-abdominal infection, complicated urinary tract infection, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia