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
  Purpose

Study 0015 (NCT00107952) 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
Drug: Vancomycin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Theravance, Inc.:

Primary Outcome Measures:
  • 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


Enrollment: 761
Study Start Date: February 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telavancin Drug: Telavancin
Telavancin 10 mg/kg/day IV for up to 21 days.
Other Names:
  • TD-6424
  • VIBATIV
Active Comparator: Vancomycin Drug: Vancomycin
Vancomycin 1 Gm IV q 12 hrs for up to 21 days

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107952

Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Theravance, Inc.
Investigators
Principal Investigator: G. Ralph Corey, MD Duke University
  More Information

No publications provided

Responsible Party: Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00107952     History of Changes
Other Study ID Numbers: 0015
Study First Received: April 11, 2005
Results First Received: November 3, 2009
Last Updated: April 6, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
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Keywords provided by Theravance, Inc.:
Nosocomial pneumonia
MRSA

Additional relevant MeSH terms:
Pneumonia, Staphylococcal
Pneumonia, Bacterial
Pneumonia
Staphylococcal Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Positive Bacterial Infections
Methicillin
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014