Ceftazidime-Avibactam compared with Doripenem Followed by Oral Therapy for hospitalized adults with complicated UTIs (Urinary Tract Infections)

Study identifier:D4280C00004

ClinicalTrials.gov identifier:NCT01599806

EudraCT identifier:2011-005722-21

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

641

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