Conditions: Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Keywords: Ceftazidime, Avibactam, Doripenem, Ciprofloxacin, sulfamethoxazole/trimethoprim, Anti-Infective Agents, Complicated Urinary Tract Infection,Acute Pyelonephritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 598
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

Detailed description:
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

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

Interventions: intervention 1: Ceftazidime - Avibactam ( CAZ-AVI) intervention 2: Doripenem intervention 3: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) intervention 4: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
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: 500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes intervention 3: Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement intervention 4: Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

Protocol document: