|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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) |
| Estimated Enrollment: | 280 |
| Study Start Date: | April 2006 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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: | Novartis Pharmaceuticals ( External Affairs ) |
| Study ID Numbers: | CCBC134A2402 |
| Study First Received: | February 1, 2007 |
| Last Updated: | July 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00430937 History of Changes |
| 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 |
|
Daptomycin Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases Skin Diseases, Infectious Teicoplanin |
Soft Tissue Infections Skin Diseases Therapeutic Uses Vancomycin Infection Pharmacologic Actions |