Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (ATTAIN1)

This study has been completed.
Sponsor:
Information provided by:
Theravance, Inc.
ClinicalTrials.gov Identifier:
NCT00107952
First received: April 11, 2005
Last updated: April 6, 2012
Last verified: April 2012

April 11, 2005
April 6, 2012
February 2005
July 2007   (final data collection date for primary outcome measure)
Clinical Response [ Time Frame: 7 - 14 days following end of antibiotic treatment ] [ Designated as safety issue: No ]

Clinical Response: Categorical (Cured, Failed or Indeterminate)

  • Failure is 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 NCT00107952 on ClinicalTrials.gov Archive Site
Not Provided
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 0015 (NCT00107952) 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bacterial Pneumonia
  • Drug: Telavancin
    Telavancin 10 mg/kg/day IV for up to 21 days.
    Other Names:
    • TD-6424
    • VIBATIV
  • Drug: Vancomycin
    Vancomycin 1 Gm IV q 12 hrs for up to 21 days
  • Experimental: Telavancin
    Intervention: Drug: Telavancin
  • Active Comparator: Vancomycin
    Intervention: Drug: Vancomycin
Barriere SL, Stryjewski ME, Corey GR, Genter FC, Rubinstein E. Effect of vancomycin serum trough levels on outcomes in patients with nosocomial pneumonia due to Staphylococcus aureus: a retrospective, post hoc, subgroup analysis of the Phase 3 ATTAIN studies. BMC Infect Dis. 2014 Apr 4;14:183. doi: 10.1186/1471-2334-14-183.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
761
July 2007
July 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00107952
0015
Yes
Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
Theravance, Inc.
Not Provided
Principal Investigator: G. Ralph Corey, MD Duke University
Theravance, Inc.
April 2012

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