NCT05905055 - P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales | Biotech Hunter

Enrollment

150

Participants

Timeline

Start Date

September 22, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions

Complicated Urinary Tract InfectionAcute PyelonephritisHospital-acquired Bacterial PneumoniaVentilator-associated Bacterial PneumoniaComplicated Intra-abdominal Infection

Interventions

DRUG

co-administration of cefepime and nacubactam

2 g cefepime and 1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes

DRUG

co-administration of aztreonam and nacubactam

2 g aztreonam and 1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes

DRUG

BAT

Dosage of BAT will be based per site's standard of care

Trial Locations (1)

Unknown

RECRUITING

Meiji Research Site, Nankoku