Conditions: Complicated Urinary Tract Infection Complicated Intra-abdominal Infection
Keywords: Ceftazidime, avibactam, metronidazone, Anti-Infectives
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 345
Healthy volunteers: no

Brief summary:
To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.

Detailed description:
An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens

Arms:
arm 1: IV treatment arm 2: IV treatment

Interventions: intervention 1: Ceftazidime - Avibactam ( CAZ-AVI) intervention 2: Best Available Therapy intervention 3: Metronidazole
Intervention descriptions: intervention 1: Ceftazidime 2000 mg and 500 mg of avibactam Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes intervention 2: Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation intervention 3: Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion

Protocol document: