Back to resultsComparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS2)
Primary Purpose
Staphylococcal Skin Infection
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Telavancin
Vancomycin
Sponsored by
About this trial
This is an interventional treatment trial for Staphylococcal Skin Infection focused on measuring cSSSI (complicated Skin and Skin Structure Infections), Staph (Staphylococcus), MRSA (Methicillin-resistant Staphylococcus Aureus)
Eligibility 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.
Sites / Locations
- Louisiana State University Health Sciences Center, Dept of Med/ER Med
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telavancin
Vancomycin
Arm Description
Outcomes
Primary Outcome Measures
Clinical Response
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00107978
First Posted
April 11, 2005
Last Updated
January 14, 2019
Sponsor
Cumberland Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00107978
Brief Title
Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
Acronym
ATLAS2
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cumberland Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Skin Infection
Keywords
cSSSI (complicated Skin and Skin Structure Infections), Staph (Staphylococcus), MRSA (Methicillin-resistant Staphylococcus Aureus)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1035 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telavancin
Arm Type
Experimental
Arm Title
Vancomycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Telavancin
Other Intervention Name(s)
VIBATIV, TD-6424
Intervention Description
Telavancin 10 mg/kg/day, IV for up to 14 days.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.
Primary Outcome Measure Information:
Title
Clinical Response
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 admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.
Time Frame
7 to 14 days after the last antibiotic dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Ralph Corey, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louisiana State University Health Sciences Center, Dept of Med/ER Med
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18444791
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.
Results Reference
result
PubMed Identifier
19095213
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.
Results Reference
result
PubMed Identifier
22416054
Citation
Stryjewski ME, Barriere SL, O'Riordan W, Dunbar LM, Hopkins A, Genter FC, Corey GR. Efficacy of telavancin in patients with specific types of complicated skin and skin structure infections. J Antimicrob Chemother. 2012 Jun;67(6):1496-502. doi: 10.1093/jac/dks081. Epub 2012 Mar 13.
Results Reference
derived
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Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
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