Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections
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|ClinicalTrials.gov Identifier: NCT01549613|
Recruitment Status : Completed
First Posted : March 9, 2012
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cellulitis Skin Infections||Drug: Daptomycin Drug: Vancomycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Active Comparator: standard treatment with daptomycin
Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol
• Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.
Active Comparator: standard treatment of vancomycin
Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
• Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
- Satisfaction of Discharge Criteria [ Time Frame: Time point at which outcome measure is assessed 30 days from the date of admission. ]RDTC cellulitis protocol discharge criteria
- Digital and Infrared Imaging [ Time Frame: Time frame begins on admission to RDTC for cellulitis and measurements will be taken every 2hour times 2 and every 4 hours until discharge from the RDTC. ]Change in lesion area and temperature
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549613
|United States, Ohio|
|University of Cincinnati, Dept. of Emergency Medicine|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||George J. Shaw, MD, PhD||University of Cincinnati, Dept. of Emergency Medicine|