Cellulitis, Skin Infections
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGDaptomycin
• Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.
DRUGVancomycin
• Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of Discharge Criteria | Time point at which outcome measure is assessed 30 days from the date of admission. | RDTC cellulitis protocol discharge criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Digital and Infrared Imaging | 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. | Change in lesion area and temperature |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment With Daptomycin Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol
Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol. | 50 |
| Standard Treatment of Vancomycin Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 11 |
Baseline characteristics
| Characteristic | Standard Treatment of Vancomycin | Total | Standard Treatment With Daptomycin |
|---|---|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 13 | 40 years STANDARD_DEVIATION 12.5 | 42 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) Asian | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) Black or African American | 14 participants | 34 participants | 20 participants |
| Race (NIH/OMB) More than one race | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) White | 34 participants | 63 participants | 29 participants |
| Sex: Female, Male Female | 15 Participants | 36 Participants | 21 Participants |
| Sex: Female, Male Male | 35 Participants | 64 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 50 | 7 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Satisfaction of Discharge Criteria
RDTC cellulitis protocol discharge criteria
Time frame: Time point at which outcome measure is assessed 30 days from the date of admission.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Treatment With Daptomycin | Satisfaction of Discharge Criteria | 15 participants |
| Standard Treatment of Vancomycin | Satisfaction of Discharge Criteria | 14 participants |
Secondary
Digital and Infrared Imaging
Change in lesion area and temperature
Time frame: 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.