Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS2)
This study has been completed.
Sponsor:
Theravance, Inc.
Information provided by:
Theravance, Inc.
ClinicalTrials.gov Identifier:
NCT00107978
First received: April 11, 2005
Last updated: December 10, 2010
Last verified: December 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
| Condition | Intervention | Phase |
|---|---|---|
|
Staphylococcal Skin Infection |
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, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections With a Focus on Patients With Infections Due to Methicillin-resistant Staphylococcus Aureus |
Resource links provided by NLM:
MedlinePlus related topics:
Skin Infections
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 to 14 days after the last antibiotic dose ] [ Designated as safety issue: No ]The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.
| Enrollment: | 1035 |
| Study Start Date: | February 2005 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Telavancin |
Drug: Telavancin
Telavancin 10 mg/kg/day, IV for up to 14 days.
Other Names:
|
| Active Comparator: Vancomycin |
Drug: Vancomycin
Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection:
- major abscess requiring surgical incision and drainage;
- infected burn (see exclusion criteria for important qualifications);
- deep/extensive cellulitis;
- infected ulcer (see exclusion criteria for important qualifications);
- wound infections
- Patients must be expected to require at least 7 days of intravenous antibiotic treatment.
Exclusion Criteria:
- Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic therapy
- Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107978
Locations
| United States, Louisiana | |
| Louisiana State University Health Sciences Center, Dept of Med/ER Med | |
| New Orleans, Louisiana, United States, 70112 | |
Sponsors and Collaborators
Theravance, Inc.
Investigators
| Principal Investigator: | G. Ralph Corey, MD | Duke University |
More Information
Publications:
| Responsible Party: | Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc. |
| ClinicalTrials.gov Identifier: | NCT00107978 History of Changes |
| Other Study ID Numbers: | 0018 |
| Study First Received: | April 11, 2005 |
| Results First Received: | November 3, 2009 |
| Last Updated: | December 10, 2010 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Argentina: Human Research Bioethics Committee Argentina: 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 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 Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Germany: Federal Ministry of Education and Research Germany: Federal Ministry of Food, Agriculture and Consumer Protection Germany: German Institute of Medical Documentation and Information Germany: Ministry of Health Germany: Paul-Ehrlich-Institut 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 Korea: Food and Drug Administration Korea: Ministry for Health, Welfare and Family Affairs Lithuania: Bioethics Committee Lithuania: State Medicine Control Agency - Ministry of Health 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 Spain: Comité Ético de Investigación Clínica Spain: Ethics Committee Spain: Ministry of Health Spain: Ministry of Health and Consumption Spain: Spanish Agency of Medicines Taiwan: Department of Health Taiwan: Institutional Review Board Taiwan: National Bureau of Controlled Drugs 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.:
|
cSSSI (complicated Skin and Skin Structure Infections) Staph (Staphylococcus) MRSA (Methicillin-resistant Staphylococcus Aureus) |
Additional relevant MeSH terms:
|
Skin Diseases, Infectious Staphylococcal Skin Infections Staphylococcal Infections Infection Skin Diseases Gram-Positive Bacterial Infections Bacterial Infections |
Skin Diseases, Bacterial Methicillin Vancomycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013