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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


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.

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


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


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 (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 prior to randomization

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

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

Locations and Contacts

Paradise Valley Hospital, 2400 E. 4th Street, National City, California 91950, United States
Additional Information

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

Page last updated: August 23, 2015

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