Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | May 2012 |
| End Date: | August 2014 |
| Contact: | George J. Shaw, MD, PhD |
| Email: | shawge@ucmail.uc.edu |
| Phone: | 513-558-8098 |
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.
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.
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.
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.
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
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