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

Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Staphylococcal Skin Infection

Intervention: Telavancin (Drug); Vancomycin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Theravance Biopharma Antibiotics, Inc.

Official(s) and/or principal investigator(s):
G. Ralph Corey, MD, Principal Investigator, Affiliation: Duke University

Summary

Study 0018 (NCT00107978) 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical Response

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have a diagnosis of one of the following complicated skin and skin

structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection:

- major abscess requiring surgical incision and drainage;

- infected burn (see exclusion criteria for important qualifications);

- deep/extensive cellulitis;

- infected ulcer (see exclusion criteria for important qualifications);

- 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

- Burns involving > 20% of body surface area or third degree/full thickness in nature,

diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.

Locations and Contacts

Louisiana State University Health Sciences Center, Dept of Med/ER Med, New Orleans, Louisiana 70112, United States
Additional Information

Starting date: February 2005
Last updated: December 10, 2010

Page last updated: August 23, 2015

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