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Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (ATTAIN2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00124020
First Posted: July 26, 2005
Last Update Posted: May 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Theravance Biopharma Antibiotics, Inc.
July 22, 2005
July 26, 2005
November 3, 2009
February 1, 2010
May 18, 2010
January 2005
May 2007   (Final data collection date for primary outcome measure)
Clinical Response [ Time Frame: 7-14 days following end of antibiotic treatment ]

Clinical Response: Categorical (Cured, Failed or Indeterminate)

  • Failure - at least one of the following:
  • Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy
  • Termination of study med due to "lack of efficacy"
  • Death on or after Day 3 attributable to primary infection
  • Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.
  • Indeterminate: Inability to determine outcome
Clinical Response
Complete list of historical versions of study NCT00124020 on ClinicalTrials.gov Archive Site
Not Provided
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Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
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
Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bacterial Pneumonia
  • Drug: Telavancin
    Telavancin 10 mg/kg/day IV for up to 21 days
    Other Names:
    • TD6424
    • VIBATIV
  • Drug: Vancomycin
    Vancomycin 1 Gm administered every 12 hrs IV for up to 21 days
  • Experimental: Telavancin
    Intervention: Drug: Telavancin
  • Active Comparator: Vancomycin
    Intervention: Drug: Vancomycin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
771
May 2007
May 2007   (Final data collection date for primary outcome measure)

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 or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.

Exclusion Criteria:

  • Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
United States
 
NCT00124020
0019
No
Not Provided
Not Provided
Steven L. Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
Theravance Biopharma Antibiotics, Inc.
Not Provided
Principal Investigator: G. Ralph Corey, MD Duke University
Theravance Biopharma Antibiotics, Inc.
May 2010

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