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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00044746
First received: September 4, 2002
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Diabetic Foot
Drug: Piperacillin/Tazobactam
Phase 4

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Enrollment: 314
Study Start Date: October 2000
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044746

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00044746     History of Changes
Other Study ID Numbers: 0910X-100468
Study First Received: September 4, 2002
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Foot
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies
Ampicillin
Piperacillin
Sulbactam
Sultamicillin
Penicillanic Acid
Piperacillin-tazobactam combination product
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014