Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections
This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections
Skin Diseases, Infectious
Soft Tissue Infections
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Assessor-Blind Study to Evaluate Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections (cSSTI)|
- Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the "Test of Cure" (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population. [ Time Frame: Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks ] [ Designated as safety issue: No ]
Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement).
Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy.
- Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit. [ Time Frame: Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks ] [ Designated as safety issue: No ]
Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated at the TOC evaluation and a superinfecting pathogen was not isolated either prior to or at the TOC evaluation.
Microbiological Failure: Persistence of one or more infecting Gram-positive pathogens or isolation of a superinfecting pathogen prior to or at the TOC evaluation.
|Study Start Date:||April 2006|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
4 mg/kg intravenous (i.v.) once daily
4 mg/kg intravenous once daily
Other Name: Cubicin
|Active Comparator: Pooled Comparator||
1 g intravenous twice daily
Other Name: VancocinDrug: Teicoplanin
400 mg intravenous once daily following a loading dose of 400 mg administered at 0, 12, 24 hours on day one.
Other Name: Targocid
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430937
|Study Director:||Novartis Pharmaceuticals||Novartis|