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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044746
• Other study ID #: 0910X-100468
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2002
• Last updated: February 7, 2013
• Start date: October 2000
• Est. completion date: January 2003

Study information

• Verified date: February 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: January 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot

Intervention

Drug:
• Piperacillin/Tazobactam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer