Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-Resistant Staphylococcus Aureus (ATLAS 1)

This study has been completed.

First Received: September 17, 2004 Last Updated: August 23, 2006 History of Changes

Sponsored by:	Theravance
Information provided by:	Theravance
ClinicalTrials.gov Identifier:	NCT00091819

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	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

Resource links provided by NLM:

Drug Information available for: Methicillin Telavancin Methicillin sodium Vancomycin

U.S. FDA Resources

Further study details as provided by Theravance:

Primary Outcome Measures:

Clinical response

Estimated Enrollment:	750
Study Start Date:	September 2004
Estimated Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091819

Locations

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

Sponsors and Collaborators

Theravance

Investigators

Principal Investigator:

G. Ralph Corey, MD

Duke Clinical Research Center

More Information

No publications provided

Study ID Numbers:	0017
Study First Received:	September 17, 2004
Last Updated:	August 23, 2006
ClinicalTrials.gov Identifier:	NCT00091819 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Staphylococcal Infections
Gram-Positive Bacterial Infections
Skin Diseases, Infectious

Methicillin
Skin Diseases
Skin Diseases, Bacterial
Vancomycin
Staphylococcal Skin Infections

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
Anti-Infective Agents
Skin Diseases
Staphylococcal Skin Infections
Infection
Pharmacologic Actions

Staphylococcal Infections
Anti-Bacterial Agents
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Methicillin
Skin Diseases, Bacterial
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2009