Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections
|Skin Diseases, Infectious Soft Tissue Infections||Drug: Daptomycin Drug: Vancomycin Drug: Teicoplanin||Phase 3|
|Study Design:||Allocation: Randomized
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 ]
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 ]
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|