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

Phase 3

Completed

• Conditions: Staphylococcal Skin Infection
• Interventions: Drug: Vancomycin; Drug: Telavancin

• Registration Number: NCT00107978
• Lead Sponsor: Cumberland Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-04-11
• Study First Submitted QC: 2005-04-11
• Study First Posted: 2005-04-12
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Results First Submitted: 2009-11-03
• Results First Submitted QC: 2010-01-08
• Results First Posted: 2010-02-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1035

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin	Vancomycin	-
Telavancin	Telavancin	-

Primary Outcome Measures

Name	Time	Method
Clinical Response	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.

Trial Locations

Locations (1)

Louisiana State University Health Sciences Center, Dept of Med/ER Med; 🇺🇸 New Orleans, Louisiana, United States