Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Treatments: Daptomycin; Vancomycin

Criteria

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