Ceftazidime-Avibactam compared with Doripenem Followed by Oral Therapy for hospitalized adults with complicated UTIs (Urinary Tract Infections)
Study identifier:D4280C00002
ClinicalTrials.gov identifier:NCT01595438
EudraCT identifier:2011-005721-43
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Phase
Phase 3
Healthy volunteers
No
Study drug
Ceftazidime - Avibactam ( CAZ-AVI), Doripenem, Either switch to oral therapy: 500 mg of Ciprofloxacin (oral), or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
Sex
All
Actual Enrollment
598
Study type
Interventional
Age
18 Years - 90 Years
Date
Study Start Date: 01 Oct 2012
Primary Completion Date: 01 Aug 2014
Study Completion Date: 01 Aug 2014
Study design
Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Cerexa, Inc.
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Ceftazidime - Avibactam ( CAZ-AVI) IV treatment | 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: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral) Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement |
| Active Comparator: Doripenem IV treatment | Drug: Doripenem 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 Drug: Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement Drug: or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral) Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement |
Contacts
Investigators
Principal Investigator
Paul Newell
AstraZeneca LP
