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

NCT ID: NCT00044746

Last Updated: 2013-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31
• Study Completion Date: 2003-01-31

Brief Summary

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

Conditions

Diabetes Mellitus; Diabetic Foot

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Piperacillin/Tazobactam

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

0910X-100468

Identifier Type: -

Identifier Source: org_study_id