Trial record 3 of 7 for:    "Pneumonia, Staphylococcal"

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

This study has been completed.
Sponsor:
Information provided by:
Theravance, Inc.
ClinicalTrials.gov Identifier:
NCT00124020
First received: July 22, 2005
Last updated: May 14, 2010
Last verified: May 2010
  Purpose

Study 0019 (NCT00124020) 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 - 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: 771
Study Start Date: January 2005
Study Completion Date: May 2007
Primary Completion Date: May 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:
  • TD6424
  • VIBATIV
Active Comparator: Vancomycin Drug: Vancomycin
Vancomycin 1 Gm administered every 12 hrs IV 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: NCT00124020

Locations
Israel
Sheba Medical Center, Infectious Disease Unit
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Theravance, Inc.
Investigators
Principal Investigator: G. Ralph Corey, MD Duke University
  More Information

No publications provided

Responsible Party: Steven L. Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00124020     History of Changes
Other Study ID Numbers: 0019
Study First Received: July 22, 2005
Results First Received: November 3, 2009
Last Updated: May 14, 2010
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Chile: Instituto de Salud Publica de Chile
China: Ethics Committee
China: Ministry of Health
China: National Natural Science Foundation
China: Food and Drug Administration
Croatia: Agency for Medicinal Product and Medical Devices
Croatia: Ethics Committee
Croatia: Ministry of Health and Social Care
Croatia: Ministry of Science, Education and Sports
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
France: Institutional Ethical Committee
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences
Georgia: Ministry of Health
Greece: Ethics Committee
Greece: Ministry of Health and Welfare
Greece: National Organization of Medicines
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Israel: Ministry of Health
Israel: The Israel National Institute for Health Policy Research and Health Services Research
Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs
Lebanon: Institutional Review Board
Lebanon: Ministry of Public Health
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Ministry of Health
Mexico: National Council of Science and Technology
Mexico: National Institute of Public Health, Health Secretariat
Philippines: Bureau of Food and Drugs
Philippines: Department of Health
Poland: Ethics Committee
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: Ministry of Public Health
Romania: National Authority for Scientific Research
Romania: National Medicines Agency
Romania: State Institute for Drug Control
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Slovakia: State Institute for Drug Control
South Africa: Department of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicines
Thailand: Ethical Committee
Thailand: Food and Drug Administration
Thailand: Khon Kaen University Ethics Committee for Human Research
Thailand: Ministry of Public Health
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

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