Phase 4
N=100
Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections
Cellulitis · Skin Infections
Bottom Line
View on ClinicalTrials.gov: NCT01549613 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Satisfaction of Discharge Criteria — 15; 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Daptomycin (Drug); Vancomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Satisfaction of Discharge Criteria |
15; 14 | — |
| SECONDARY Digital and Infrared Imaging |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01549613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.