Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections

Phase 3

Terminated

• Conditions: Skin Diseases, Infectious; Soft Tissue Infections
• Interventions: Drug: Daptomycin; Drug: Vancomycin; Drug: Teicoplanin

• Registration Number: NCT00430937
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-02-01
• Study First Submitted QC: 2007-02-01
• Study First Posted: 2007-02-02
• Primary Completion: 2008-03
• Results First Submitted: 2010-12-07
• Results First Submitted QC: 2010-12-07
• Results First Posted: 2011-01-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daptomycin	Daptomycin	4 mg/kg intravenous (i.v.) once daily
Pooled Comparator	Vancomycin	-
Pooled Comparator	Teicoplanin	-

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.	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.