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NCT01595438 · ClinicalTrials.gov registry record · Phase 3
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 598
- Enrollment target
NCT01595438: Completed Phase 3 study, sponsored by Pfizer.
NCT01595438 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 598 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01595438, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 598 participants
- Enrollment target
Study 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
Primary Outcome
Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary ou
Interventions
- DRUG 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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 598 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
What the finished NCT01595438 record still lists
NCT01595438 is an interventional study that assigns participants to a tested intervention. The registered 598 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 4 interventions - of which Ceftazidime - Avibactam ( CAZ-AVI) is the first listed.
NCT01595438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01595438 about?
NCT01595438 is a clinical study titled "Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)". 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
What is the current status of trial NCT01595438?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 598 participants. The study started on 2012-10. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01595438?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT01595438?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01595438's enrollment target sits among peer trials
598 640th of 2000 higher than 1,361 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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