Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus - Full Text View

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:

MedlinePlus related topics: Pneumonia

Drug Information available for: Vancomycin Vancomycin hydrochloride Staphylococcus aureus Telavancin

U.S. FDA Resources

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 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 Belgium: Directorate general for the protection of Public health: Medicines Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board Belgium: Ministry of Social Affairs, Public Health and the Environment Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Brazil: Ethics Committee Brazil: Ministry of Health Brazil: National Committee of Ethics in Research Brazil: National Health Surveillance Agency 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 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 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 Greece: Ethics Committee Greece: Ministry of Health and Welfare Greece: National Organization of Medicines India: Indian Council of Medical Research 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 Italy: Ethics Committee Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Malaysia: Ministry of Health Malta: Medicines Authority Peru: Ethics Committee Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Peru: Ministry 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 South Africa: Department of Health South Africa: Human Research Ethics Committee South Africa: Medicines Control Council South Africa: National Health Research Ethics Council Taiwan: Department of Health Taiwan: Institutional Review Board Taiwan: National Bureau of Controlled Drugs Turkey: Ministry of Health United Kingdom: Department of Health United Kingdom: Food Standards Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Health Service United Kingdom: Research Ethics Committee United States: Food and Drug Administration

Keywords provided by Theravance, Inc.:

Nosocomial pneumonia
MRSA

Additional relevant MeSH terms:

Pneumonia, Bacterial
Pneumonia
Staphylococcal Infections
Pneumonia, Staphylococcal
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 May 19, 2013

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