Study Evaluating the Safety and Efficacy of Piperacillin/Tazobactam and Ampicillin/Sulbactam in Patients With Diabetic Foot Infections

February 7, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

An Open-label, Randomized Study Comparing the Efficacy and Safety of Piperacillin/Tazobactam and Ampicillin/Sulbactam Administered Intravenously in the Empirical Treatment of Foot Infections in Diabetic Inpatients

Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy and Safety data in Diabetic Inpatients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

314

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Patients with diabetes mellitus
  • Inpatient
  • Have 1 or more infected ulcer(s) below the ankle

Exclusion Criteria

  • Must not have gangrene or severely impaired arterial supply in your foot
  • Must not have a bone infection in the area of your ulcer
  • Must not have allergies to penicillins

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Primary Completion (Actual)

January 1, 2003

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

September 4, 2002

First Submitted That Met QC Criteria

September 5, 2002

First Posted (Estimate)

September 6, 2002

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0910X-100468

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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