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DRUG4 trials

Sponsors

Centre Hospitalier Universitaire De Lille, Meiji Seika Pharma Co. Ltd., Melinta Therapeutics LLC

Conditions

Acute Bacterial Skin and Skin Structure InfectionsComplicated urinary tract infection (cUTI)Complicated urinary tract infection (cUTI) and acute uncomplicated pyelonephritis (AP)Patients (male or female) ≥18 years old with Detrusor overactivity (DO) in multiple sclerosis (MS) or spinal cord injured (SCI).acute uncomplicated pyelonephritis (AP)and complicated intra-abdominal infection (cIAI)hospital acquired bacterial pneumonia (HABP)ventilator-associated bacterial pneumonia (VABP)

Phase 2

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
ANTIBIOBONTA - Assessment of the interest of a peri-operative antibiotic strategy applied to patients with asymptomatic bacteriuria undergoing intra-vesical botulinum toxin A injections
Not yet recruitingCTIS2024-515107-19-00
Centre Hospitalier Universitaire De LillePatients (male or female) ≥18 years old with Detrusor overactivity (DO) in multiple sclerosis (MS) or spinal cord injured (SCI).
Target: 526Updated: 2025-11-10