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NCT01644643 · ClinicalTrials.gov registry record · Phase 3

Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

A Phase 3 study of Complicated Urinary Tract Infection and Complicated Intra-abdominal Infection, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
345
Enrollment target
20
Study locations

NCT01644643: Completed Phase 3 study of Complicated Urinary Tract Infection and Complicated Intra-abdominal Infection, sponsored by Pfizer.

NCT01644643 is a Phase 3 study of Complicated Urinary Tract Infection and Complicated Intra-abdominal Infection that has completed, run by Pfizer. The registered enrollment target is 345 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01644643, a Phase 3 study of Complicated Urinary Tract Infection and Complicated Intra-abdominal Infection, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
345 participants
Enrollment target
20
Study locations

Study Summary

To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.

Primary Outcome

Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).

Conditions Studied

Complicated Urinary Tract Infection Complicated Intra-abdominal Infection

Interventions

  • DRUG Metronidazole
  • DRUG Ceftazidime - Avibactam ( CAZ-AVI)
  • DRUG Best Available Therapy

Study Locations (20)

Other

  • Research Site - El Talar
  • Research Site - La Plata
  • Research Site - Pazardzhik
  • Research Site - Pleven
  • Research Site - Rousse
  • Research Site - Sofia
  • Research Site - Varna
  • Research Site - Veliko Tarnovo
  • Research Site - Slavonski Brod
  • Research Site - Zagreb
  • Research Site - Prague
  • Research Site - Tours
  • Research Site - Nazareth
  • Research Site - Petah Tikva
  • Research Site - Ramat Gan
  • Research Site - Tel Aviv
  • Research Site - Guadalajara
  • Research Site - Mexico City

Louisiana

  • Research Site - Shreveport

Ohio

  • Research Site - Lima

Trial Details

FieldValue
Enrollment Target 345 participants
Start Date 2013-01
Est. Completion 2014-09
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT01644643 record still lists

NCT01644643 is an interventional study that assigns participants to a tested intervention. The registered 345 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 (55% lower).

The record links to 2 conditions, with Complicated Urinary Tract Infection appearing as the primary indexed condition, and to 3 interventions - of which Metronidazole is the first listed.

NCT01644643 names 20 study sites across 3 states, led by Other, Louisiana, Ohio.

Frequently Asked Questions

What is clinical trial NCT01644643 about?

NCT01644643 is a clinical study titled "Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens". To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.

What is the current status of trial NCT01644643?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 345 participants. The study started on 2013-01. Estimated completion is 2014-09.

What conditions does trial NCT01644643 study?

This clinical trial studies the following conditions: Complicated Urinary Tract Infection, Complicated Intra-abdominal Infection.

What interventions are being tested in trial NCT01644643?

The interventions under investigation include: Metronidazole (DRUG), Ceftazidime - Avibactam ( CAZ-AVI) (DRUG), Best Available Therapy (DRUG).

Who is sponsoring clinical trial NCT01644643?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01644643 being conducted?

This trial has 20 study locations across Louisiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Where NCT01644643's enrollment target sits among peer trials

345 1050th of 2000 higher than 951 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

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Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01644643, the US trial registry maintained by the National Library of Medicine. NCT01644643 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.