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| Tracking Information | |||||
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| First Received Date ICMJE | February 21, 2006 | ||||
| Last Updated Date | December 14, 2006 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
investigating the differences in speed and degree of symptom resolution between CUBICIN and vancomycin | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00295178 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
frequency of Serious Adverse Events between daptomycin and vancomycin will be described | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas | ||||
| Official Title ICMJE | A Multicenter, Randomized Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in the Treatment of Cellulitis or Erysipelas | ||||
| Brief Summary | This study is designed to investigate the difference in speed and degree of symptom resolution between daptomycin and vancomycin in subjects treated for cellulitis or erysipelas by evaluation of the following parameters:
Additionally, the difference in frequency of Adverse Events between daptomycin and vancomycin will be described. |
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| Detailed Description | same as above |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment | ||||
| Condition ICMJE | Cellulitis | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Pertel PE, Eisenstein BI, Link AS, Donfrid B, Biermann EJ, Bernardo P, Martone WJ. The efficacy and safety of daptomycin vs. vancomycin for the treatment of cellulitis and erysipelas. Int J Clin Pract. 2009 Mar;63(3):368-75. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 80 | ||||
| Completion Date | August 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00295178 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | DAP-4CELL-05-02 | ||||
| Study Sponsor ICMJE | Cubist Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Cubist Pharmaceuticals | ||||
| Verification Date | December 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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