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Nacubactam

DRUG3 trials

Sponsors

Meiji Seika Pharma Co. Ltd., Hoffmann-La Roche

Conditions

Complicated urinary tract infection (cUTI)Complicated urinary tract infection (cUTI) and acute uncomplicated pyelonephritis (AP)Gram-negative Bacterial Infectionsacute uncomplicated pyelonephritis (AP)and complicated intra-abdominal infection (cIAI)hospital acquired bacterial pneumonia (HABP)ventilator-associated bacterial pneumonia (VABP)

Phase 1

A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants
CompletedNCT03182504
Hoffmann-La RocheGram-negative Bacterial Infections
Start: 2017-06-15End: 2017-08-10Updated: 2018-04-23

Phase 3

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 (OP0595-6)
CompletedCTIS2024-515180-56-00
Meiji Seika Pharma Co. Ltd.acute uncomplicated pyelonephritis (AP), and complicated intra-abdominal infection (cIAI), Complicated urinary tract infection (cUTI) +2
Start: 2023-06-26End: 2025-09-01Target: 96Updated: 2025-06-17
A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis, in Adults (OP0595-5)
CompletedCTIS2024-515463-55-00
Meiji Seika Pharma Co. Ltd.Complicated urinary tract infection (cUTI) and acute uncomplicated pyelonephritis (AP)
Start: 2023-05-18End: 2024-11-26Target: 436Updated: 2024-10-03