Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections
Completed · Phase 4
Conditions studied: Cellulitis, Skin Infections
In brief
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.
Key facts
- Study ID
- NCT01549613
- Run by
- University of Cincinnati
- People needed
- 104
- Starts
- 2012-05-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2014-08-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Cincinnati, Dept. of Emergency Medicine — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.