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

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ClinicalTrials.gov Identifier: NCT00044746
Recruitment Status : Completed
First Posted : September 6, 2002
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Masking: None (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
Study Start Date : October 2000
Primary Completion Date : January 2003
Study Completion Date : January 2003

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U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00044746     History of Changes
Other Study ID Numbers: 0910X-100468
First Posted: September 6, 2002    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013

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
Tazobactam
Penicillanic Acid
Piperacillin
Ampicillin
Piperacillin, tazobactam drug combination
Sulbactam
Sultamicillin
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action