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Completed Phase 3 Interventional Results available

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

ClinicalTrials.gov ID: NCT01595438

Public ClinicalTrials.gov record NCT01595438. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 7:43 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT01595438
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pfizer
Industry
Enrollment
598 participants

Conditions and interventions

Interventions

  • Ceftazidime - Avibactam ( CAZ-AVI) Drug
  • Doripenem Drug
  • Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) Drug
  • or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral) Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2012
Primary completion
Jul 31, 2014
Completion
Jul 31, 2014
Last update posted
Sep 5, 2017

2012 – 2014

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Research Site Sylmar California
Research Site Royal Oak Michigan
Research Site Lima Ohio

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 77 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01595438, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 5, 2017 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01595438 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →