Clinical Trial: Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections with a Focus on Methicillin-resistant Staphylococcus aureus


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Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections with a Focus on Methicillin-resistant Staphylococcus aureus

This study is currently recruiting patients.

Sponsored by:	Theravance
Information provided by:	Theravance

Purpose

Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.

Condition	Treatment or Intervention	Phase
Staphylococcal Skin Infection	Drug: Telavancin	Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase 3, Randomized, Double Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram positive Skin and Skin Structure Infections with a Focus on Patients with Infections Due to Methicillin-resistant Staphylococcus aureus

Further Study Details:

Primary Outcomes: Clinical response

Expected Total Enrollment: 750

Study start: September 2004

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Patients must have a diagnosis of one of the following complicated skin and skin structure infections with Methicillin Resistant Staphylococcus aureus (MRSA) either suspected or confirmed as the major cause of the infection: * major abscess requiring surgical incision and drainage * infected burn * deep/extensive cellulitis * infected ulcer * wound infections
Patients must be expected to require at least 7 days of intravenous antibiotic treatment

Exclusion Criteria:

Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic therapy prior to randomization

Location and Contact Information

California
Paradise Valley Hospital, National City, California, 91950, United States; Recruiting

William O'Riordan, MD 619-470-4236

Study chairs or principal investigators

G. Ralph Corey, MD, Principal Investigator, Duke Clinical Research Center

More Information

Study ID Numbers: 0017
Record last reviewed: September 2004
Record first received: September 17, 2004
ClinicalTrials.gov Identifier: NCT00091819
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10

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