CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 641 enrolled
Drug / intervention
Ceftazidime - Avibactam ( CAZ-AVI) +3 moredrug
Likely dose
Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01599806
NCT01599806Phase 3Completed
CompareCT.gov

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

Pfizer·interventional·Posted May 16, 2012·Updated Sep 6, 2017

In Brief

A Phase 3 clinical trial evaluating Ceftazidime - Avibactam ( CAZ-AVI), Doripenem, and 2 other interventions for Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis. Completed, enrolled 641 participants across 57 sites in 17 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
CountriesArgentina, Bulgaria, Croatia, Czechia, Germany, Israel, Italy, Mexico, Peru, Poland, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United States
CollaboratorsForest Laboratories

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2012
Enrollment StartOct 1, 2012
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.1 years ago

Interventions

Ceftazidime - Avibactam ( CAZ-AVI)drug

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

Doripenemdrug

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

Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)drug

Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)drug

Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement