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

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.
 
ClinicalTrials.gov Identifier: NCT00107952
Recruitment Status : Completed
First Posted : April 12, 2005
Results First Posted : December 8, 2009
Last Update Posted : January 16, 2019
Sponsor:
Information provided by:
Cumberland Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 11, 2005
First Posted Date  ICMJE April 12, 2005
Results First Submitted Date  ICMJE November 3, 2009
Results First Posted Date  ICMJE December 8, 2009
Last Update Posted Date January 16, 2019
Study Start Date  ICMJE February 2005
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
Clinical Response [ Time Frame: 7 - 14 days following end of antibiotic treatment ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Clinical Response
Change History Complete list of historical versions of study NCT00107952 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Official Title  ICMJE 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
Brief Summary Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Pneumonia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: November 3, 2009)
761
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
625
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00107952
Other Study ID Numbers  ICMJE 0015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
Study Sponsor  ICMJE Cumberland Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: G. Ralph Corey, MD Duke University
PRS Account Cumberland Pharmaceuticals
Verification Date January 2019

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