Comparison of Telavancin and Vancomycin for Hospital-Acquired Pneumonia Due to Methicillin-Resistant Staphylococcus Aureus (ATTAIN 2)

This study has been completed.

Sponsored by:	Theravance
Information provided by:	Theravance
ClinicalTrials.gov Identifier:	NCT00124020

Purpose

This study (0019) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.

Condition	Intervention	Phase
Bacterial Pneumonia	Drug: Telavancin	Phase III

MedlinePlus related topics: Pneumonia

Drug Information available for: Vancomycin Vancomycin hydrochloride Methicillin Telavancin Methicillin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia With a Focus on Patients With Infections Due to Methicillin-Resistant Staphylococcus Aureus

Further study details as provided by Theravance:

Primary Outcome Measures:

Clinical response

Estimated Enrollment:	625
Study Start Date:	January 2005
Study Completion Date:	May 2007

Eligibility

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

Criteria

Inclusion Criteria:

Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic-care facility

Exclusion Criteria:

Received more than 24 hours of potentially effective systemic (intravenous [IV]/intramuscular [IM] or by mouth [PO]) antibiotic therapy prior to randomization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124020

Locations

United States, Ohio
Regional Infectious Diseases-Infusion Center
Lima, Ohio, United States, 45801

Sponsors and Collaborators

Theravance

Investigators

Principal Investigator:

G. Ralph Corey, MD

Duke University

More Information

Study ID Numbers:	0019
Study First Received:	July 22, 2005
Last Updated:	May 17, 2007
ClinicalTrials.gov Identifier:	NCT00124020
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Methicillin
Respiratory Tract Infections

Respiratory Tract Diseases
Lung Diseases
Pneumonia, Bacterial
Vancomycin
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009