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CILASTATIN AND RELEBACTAM

DRUG3 trials

Sponsors

Meiji Seika Pharma Co. Ltd., Centre Hospitalier Universitaire De Nimes, Assistance Publique Hopitaux De Paris

Conditions

Complicated urinary tract infection (cUTI)Pyogenic liver abscessSerious infections in critically ill patients treated with antibioticsacute uncomplicated pyelonephritis (AP)and complicated intra-abdominal infection (cIAI)hospital acquired bacterial pneumonia (HABP)ventilator-associated bacterial pneumonia (VABP)

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

Phase 4

TIME-TO-LIA : Optimal Duration of Antibiotic Therapy in Drained Pyogenic Liver Abscess: 3 weeks versus 6 weeks, a non-inferiority trial
Not yet recruitingCTIS2025-520940-14-00
Assistance Publique Hopitaux De ParisPyogenic liver abscess
Target: 456Updated: 2025-10-06
Defining Antibiotic Levels in Intensive care patients (DALI-2) protocol - A multi-national pharmacokinetic/pharmacodynamic cohort study to determine whether contemporary antibiotic dosing for critically ill patients achieves therapeutic exposures.
Not yet recruitingCTIS2024-516232-10-00
Centre Hospitalier Universitaire De NimesSerious infections in critically ill patients treated with antibiotics
Target: 200Updated: 2025-10-17