Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (ATTAIN1)
This study has been completed.
Sponsor:
Theravance Biopharma Antibiotics, Inc.
Information provided by:
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT00107952
First received: April 11, 2005
Last updated: August 13, 2014
Last verified: August 2014
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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:
Drug Information available for:
Vancomycin
Vancomycin hydrochloride
Staphylococcus aureus
Telavancin
Telavancin hydrochloride
U.S. FDA Resources
Further study details as provided by Theravance Biopharma Antibiotics, 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:
|
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00107952
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 Biopharma Antibiotics, Inc.
Investigators
| Principal Investigator: | G. Ralph Corey, MD | Duke University |
More Information
No publications provided by Theravance Biopharma Antibiotics, Inc.
Additional 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 |
| Study First Received: | April 11, 2005 |
| Results First Received: | November 3, 2009 |
| Last Updated: | August 13, 2014 |
| 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: Federal Agency for Medicines and Health Products, FAMHP 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 Pública 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 Biopharma Antibiotics, Inc.:
|
Nosocomial pneumonia MRSA |
Additional relevant MeSH terms:
|
Pneumonia Staphylococcal Infections Bacterial Infections Gram-Positive Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Telavancin Vancomycin Anti-Bacterial Agents Anti-Infective Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015