Expired Study
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New Orleans, Louisiana 70112


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.


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.


Study is Available At:


Original ID:

0018


NCT ID:

NCT00107978


Secondary ID:


Study Acronym:

ATLAS2


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:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


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:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1035


Enrollment Type:

Actual


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
Name:Telavancin
Description:Telavancin 10 mg/kg/day, IV for up to 14 days.
Arm Name:Telavancin
Other Name:VIBATIV
Intervention Type:Drug
Name:Vancomycin
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.
PMID:19095213
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.
PMID:18444791

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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