Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy and Safety data in Diabetic Inpatients...
Date First Received: September 4, 2002
Last Updated: October 9, 2007
Verified by: Wyeth, October 2007
Clinical Trial Phase: Phase 4 | Start Date:
Overall Status: Completed
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy and Safety data in Diabetic Inpatients.
Study Type: Interventional
Study Design: Treatment, Open Label
Intervention(s) in this Clinical Trial
- Drug: Piperacillin/Tazobactam
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor, MD Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00044746
Study ID Number: 0910X-100468
ClinicalTrials.gov Identifier: NCT00044746
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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