Expired Study
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New Orleans, Louisiana 70112


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.


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.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:


Brief Title:

Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus

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 Staphy

Overall Status:


Study Phase:

Phase 3



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cumberland Pharmaceuticals

Oversight 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 Pública 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

Reasons Why Stopped:

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Study Design:

Number of Arms:


Number of Groups:


Total Enrollment:


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Overall Contact Information

Official Name:G. Ralph Corey, MD
Principal Investigator
Duke University

Study Dates

Start Date:February 2005
Completion Date:May 2006
Completion Type:Actual
Primary Completion Date:May 2006
Primary Completion Type:Actual
Verification Date:January 2019
Last Changed Date:January 14, 2019
First Received Date:April 11, 2005
First Results Date:November 3, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Clinical Response
Time Frame:7 to 14 days after the last antibiotic dose
Safety Issues:False
Description: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 Interventions

Intervention Type:Drug
Description:Telavancin 10 mg/kg/day, IV for up to 14 days.
Arm Name:Telavancin
Other Name:VIBATIV
Intervention Type:Drug
Description:Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.
Arm Name:Vancomycin

Study Arms

Study Arm Type:Experimental
Arm Name:Telavancin
Study Arm Type:Active Comparator
Arm Name:Vancomycin

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Cumberland Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Wilson SE, O'Riordan W, Hopkins A, Friedland HD, Barriere SL, Kitt MM; ATLAS Investigators. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections associated with surgical procedures. Am J Surg. 2009 Jun;197(6):791-6. doi: 10.1016/j.amjsurg.2008.05.012. Epub 2008 Dec 18.
Reference Type:Results Reference
Citation:Stryjewski ME, Graham DR, Wilson SE, O'Riordan W, Young D, Lentnek A, Ross DP, Fowler VG, Hopkins A, Friedland HD, Barriere SL, Kitt MM, Corey GR; Assessment of Telavancin in Complicated Skin and Skin-Structure Infections Study. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clin Infect Dis. 2008 Jun 1;46(11):1683-93. doi: 10.1086/587896.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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