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

Staphylococcal Skin Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091819
• Other study ID #: 0017
• Status: Completed
• Phase: Phase 3
• Start date: January 2005
• Est. completion date: June 2006

Study information

• Verified date: January 2019
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 862
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cellulitis
• Communicable Diseases
• Infection
• Skin Diseases, Infectious
• Staphylococcal Infections
• Staphylococcal Skin Infection
• Staphylococcal Skin Infections

Intervention

Drug:
• Telavancin
Telavancin 10 mg/kg/day, IV for up to 14 days.
• Vancomycin
Vancomycin 1 Gm IV q 12 hrs for up to 14 days.

Locations

Country	Name	City	State
United States	Paradise Valley Hospital, 2400 E. 4th Street	National City	California

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 vancomyc — View 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):79 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7-14 days following end of antibiotic treatment