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

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ClinicalTrials.gov Identifier: NCT00107952
Recruitment Status : Completed
First Posted : April 12, 2005
Results First Posted : December 8, 2009
Last Update Posted : August 18, 2014
Sponsor:
Information provided by:
Theravance Biopharma Antibiotics, Inc.

Study Description
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Brief Summary:
Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.

Condition or disease Intervention/treatment Phase
Bacterial Pneumonia Drug: Telavancin Drug: Vancomycin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 761 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107952


Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Theravance Biopharma Antibiotics, Inc.
Investigators
Principal Investigator: G. Ralph Corey, MD Duke University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Posted: April 12, 2005    Key Record Dates
Results First Posted: December 8, 2009
Last Update Posted: August 18, 2014
Last Verified: August 2014

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Nosocomial pneumonia
MRSA

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