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

Primary Purpose

Diabetes Mellitus, Diabetic Foot

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Piperacillin/Tazobactam
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 4, 2002
    Last Updated
    February 7, 2013
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00044746
    Brief Title
    Study Evaluating the Safety and Efficacy of Piperacillin/Tazobactam and Ampicillin/Sulbactam in Patients With Diabetic Foot Infections
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2000 (undefined)
    Primary Completion Date
    January 2003 (Actual)
    Study Completion Date
    January 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Diabetic Foot
    Keywords
    Diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Masking
    None (Open Label)
    Enrollment
    314 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Piperacillin/Tazobactam

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor, MD
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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