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

• ClinicalTrials.gov Identifier: NCT00091819
• Recruitment Status: Completed
• First Posted: September 21, 2004
• Results First Posted: December 8, 2009
• Last Update Posted: January 16, 2019
• Sponsor: Cumberland Pharmaceuticals
• Information provided by: Cumberland Pharmaceuticals

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.

Condition or disease	Intervention/treatment	Phase
Staphylococcal Skin Infection	Drug: Telavancin; Drug: Vancomycin	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 862 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: January 2005
• Actual Primary Completion Date: June 2006
• Actual Study Completion Date: June 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: Telavancin	Drug: Telavancin; Telavancin 10 mg/kg/day, IV for up to 14 days.; Other Names: VIBATIV; TD-6424
Active Comparator: Vancomycin	Drug: Vancomycin; Vancomycin 1 Gm IV q 12 hrs for up to 14 days.

Outcome Measures

Primary Outcome Measures :

1. Clinical Response [ Time Frame: 7-14 days following end of antibiotic treatment ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Paradise Valley Hospital, 2400 E. 4th Street

National City, California, United States, 91950

Sponsors and Collaborators

Cumberland Pharmaceuticals

Investigators

• Principal Investigator: G. Ralph Corey, MD; Duke University

More Information

Publications of Results:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
• ClinicalTrials.gov Identifier: NCT00091819
• Other Study ID Numbers: 0017
• First Posted: September 21, 2004
• Results First Posted: December 8, 2009
• Last Update Posted: January 16, 2019
• Last Verified: January 2019

Keywords provided by Cumberland Pharmaceuticals:

staph; MRSA; cSSSI

Additional relevant MeSH terms:

Infection; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Suppuration; Connective Tissue Diseases; Inflammation; Pathologic Processes; Skin Diseases; Skin Diseases, Bacterial; Vancomycin; Methicillin; Telavancin; Anti-Bacterial Agents; Anti-Infective Agents