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Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS1)

Primary Purpose

Staphylococcal Skin Infection

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Telavancin
Vancomycin
Sponsored by
Cumberland Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcal Skin Infection focused on measuring staph, MRSA, cSSSI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have a diagnosis of one of the following complicated skin and skin structure infections with Methicillin Resistant Staphylococcus aureus (MRSA) 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 prior to randomization Burns involving > 20% of body surface area or third-degree/full-thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fascitis, gas gangrene, or mediastinitis.

Sites / Locations

  • Paradise Valley Hospital, 2400 E. 4th Street

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 a patient's clinical signs and symptoms at the specified evaluation 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

First Posted
September 17, 2004
Last Updated
January 14, 2019
Sponsor
Cumberland Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00091819
Brief Title
Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
Acronym
ATLAS1
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
January 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cumberland Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study 0017 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
staph, MRSA, cSSSI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
862 (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 q 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 a patient's clinical signs and symptoms at the specified evaluation 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
7-14 days following end of antibiotic treatment

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 Methicillin Resistant Staphylococcus aureus (MRSA) 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 prior to randomization Burns involving > 20% of body surface area or third-degree/full-thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fascitis, 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
Paradise Valley Hospital, 2400 E. 4th Street
City
National City
State/Province
California
ZIP/Postal Code
91950
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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