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

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.

Study Overview

• Status: Completed
• Conditions: Cellulitis; Skin Infections
• Intervention / Treatment: Drug: Daptomycin; Drug: Vancomycin

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati, Dept. of Emergency Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Drug: 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.
ACTIVE_COMPARATOR: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction of Discharge Criteria	RDTC cellulitis protocol discharge criteria	Time point at which outcome measure is assessed 30 days from the date of admission.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digital and Infrared Imaging	Change in lesion area and temperature	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.

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: George J. Shaw, MD, PhD, University of Cincinnati, Dept. of Emergency Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: February 8, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (ESTIMATE): March 9, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 1, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Inflammation; Disease Attributes; Connective Tissue Diseases; Suppuration; Emergencies; Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin; Daptomycin
• Other Study ID Numbers: 11-11-03-06