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Completed

NCT Number: NCT00107978

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

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.

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Key information

Conditions

Staphylococcal Skin Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Louisiana State University Health Sciences Center, Dept of Med/ER Med

New Orleans, Louisiana, 70112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telavancin

Drug

Telavancin 10 mg/kg/day, IV for up to 14 days.

Other names: VIBATIV, TD-6424

Vancomycin

Drug

Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.

Primary outcomes

  1. Clinical Response

    Time frame: 7 to 14 days after the last antibiotic dose

    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.

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: ATLAS2

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 12, 2005
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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