Cellulitis Clinical Trial
Official title:
Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections
Verified date | July 2014 |
Source | University of Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Admitted to RDTC to the Cellulitis Protocol - 18 yrs old or greater - Able and willing to give informed consent - Hemodynamically stable (systolic blood pressure >90mmHg and heart rate <120 beats per minute) Exclusion Criteria: - Antibiotics given prior to enrollment - Suspected necrotizing infection - Diabetic foot ulcer - Genitourinary involvement - Post operative infection (not including simple wound closure infection) - Suspected gouty or septic arthritis - Chronic Lymphangitis - Requiring routine hemodialysis - Patient reported allergy to Vancomycin - Patient reported allergy to Daptomycin - Participation in another investigational treatment study within 30 days prior to enrollment - Prisoner - Pregnant or breast-feeding - Complicated skin and skin structure infection of the face |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Cincinnati, Dept. of Emergency Medicine | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Satisfaction of Discharge Criteria | RDTC cellulitis protocol discharge criteria | Time point at which outcome measure is assessed 30 days from the date of admission. | No |
Secondary | Digital and Infrared Imaging | Change in lesion area and temperature | 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. | No |
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