Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS2)

This study has been completed.

Sponsor:

Information provided by:

Theravance

ClinicalTrials.gov Identifier:

NCT00107978

First received: April 11, 2005

Last updated: December 10, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 11, 2005

Last Updated Date

December 10, 2010

Start Date ^ICMJE

February 2005

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical Response [ Time Frame: 7 to 14 days after the last antibiotic dose ] [ Designated as safety issue: No ]

The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.

Original Primary Outcome Measures ^ICMJE

Clinical response

Change History

Complete list of historical versions of study NCT00107978 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Staphylococcal Skin Infection

Intervention ^ICMJE

Drug: Telavancin
Telavancin 10 mg/kg/day, IV for up to 14 days.
Other Names:
- VIBATIV
- TD-6424
Drug: Vancomycin
Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.

Study Arm (s)

Experimental: Telavancin
Intervention: Drug: Telavancin
Active Comparator: Vancomycin
Intervention: Drug: Vancomycin

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1035

Completion Date

May 2006

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00107978

Other Study ID Numbers ^ICMJE

0018

Has Data Monitoring Committee

Yes

Responsible Party

Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.

Study Sponsor ^ICMJE

Theravance

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

G. Ralph Corey, MD

Duke University

Information Provided By

Theravance

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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