NCT01644643

Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Complicated Urinary Tract Infection
• Complicated Intra-abdominal Infection

Interventions

Type	Name	Description
DRUG	Ceftazidime - Avibactam ( CAZ-AVI)	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
DRUG	Best Available Therapy	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
DRUG	Metronidazole	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

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-07-19
• Last updated: 2017-09-29
• Results posted: 2015-12-14

Locations

43 sites across 18 countries: United States, Argentina, Bulgaria, Croatia, Czechia, France, Israel, Mexico, Peru, Philippines, Poland, Romania, Russia, South Africa, South Korea, Spain, Turkey (Türkiye), Ukraine