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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00430937 |
Purpose
This study will evaluate the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections
| Condition | Intervention | Phase |
|---|---|---|
|
Skin Diseases, Infectious Soft Tissue Infections |
Drug: Daptomycin Drug: Vancomycin Drug: Teicoplanin |
Phase IV |
| Study Type: | Interventional |
| 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) |
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 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.
| Enrollment: | 280 |
| Study Start Date: | April 2006 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Daptomycin
4 mg/kg intravenous (i.v.) once daily
|
Drug: Daptomycin
4 mg/kg intravenous once daily
Other Name: Cubicin
|
| Active Comparator: Pooled Comparator |
Drug: Vancomycin
1 g intravenous twice daily
Other Name: Vancocin
Drug: 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Inclusion criteria:
Exclusion criteria:
cSSTIs of the following categories:
Contacts and Locations
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00430937 History of Changes |
| Other Study ID Numbers: | CCBC134A2402 |
| Study First Received: | February 1, 2007 |
| Results First Received: | December 7, 2010 |
| Last Updated: | February 25, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; France: French Health Products Safety Agency |
|
Complicated Skin and Soft Tissue Infections. Daptomycin, Vancomycin, Teicoplanin Complicated skin and soft tissue infections |
|
Communicable Diseases Infection Skin Diseases Skin Diseases, Infectious Soft Tissue Infections Vancomycin |
Daptomycin Teicoplanin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |