Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections
This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the Emergency Department (ED) treatment of complicated skin and skin structure infection in the Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who are admitted to the RDTC cellulitis protocol in the ED will be randomized to either vancomycin, which is currently an accepted care standard in the RDTC cellulitis protocol, or daptomycin, which is the experimental treatment in this study. The primary hypothesis is that daptomycin treatment is as efficacious as standard therapy in the treatment of ED cellulitis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections|
- Satisfaction criteria [ Time Frame: Time point at which outcome measure is assessed 30 days from the date of admission. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]Change in lesion area and temperature
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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.
Specific Aim 1: Compare the efficacy of daptomycin to the efficacy of vancomycin for the treatment of complicated skin and skin structure infection in the ED. Patients eligible for the RDTC Cellulitis Treatment Protocol will be screened for inclusion in the study. After informed consent, patients will be randomized to receive either daptomycin or vancomycin (1:1 ratio). A case report form (CRF) detailing medical history, clinical characteristics, and treatments will be completed. The patients will be evaluated for meeting RDTC discharge criteria. The following time points will be collected: 1. actual time patient meets discharge criteria based on the RDTC cellulitis protocol; 2. time of disposition defined as the time treating physician writes discharge orders; and, 3. time the patient actually leaves the emergency department. Subsequently, the patient will be followed up by telephone to ascertain whether a change in antibiotic therapy or a return ED visit for complicated skin and skin structure infection occurred within 30 days of the initial RDTC enrollment Specific Aim 2: Compare the change in area and erythema of the cellulitic lesion between patients treated with daptomycin and patients treated with vancomycin. Patients enrolled in the study will have serial digital photographs of their primary lesion taken. The images will be processed blinded to clinical data and asynchronous to the ED stay. The change in lesion area and erythema will be calculated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549613
|Contact: George J. Shaw, MD, PhDemail@example.com|
|United States, Ohio|
|University of Cincinnati, Dept. of Emergency Medicine||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: D.Beth Wayne, RN,JD 513-558-8490 firstname.lastname@example.org|
|Contact: Greg Fermann, MD 513-558-8102 email@example.com|
|Principal Investigator: George J Shaw, MD,PhD|
|Principal Investigator:||George J. Shaw, MD, PhD||University of Cincinnati, Dept. of Emergency Medicine|