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

This study is currently recruiting participants.
Verified January 2013 by University of Cincinnati
Sponsor:
Information provided by (Responsible Party):
George Shaw, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01549613
First received: February 8, 2012
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Cellulitis
Skin Infections
 Drug: Daptomycin
Drug: Vancomycin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Satisfaction criteria [ Time Frame: Time point at which outcome measure is assessed 30 days from the date of admission. ] [ Designated as safety issue: No ]
    RDTC cellulitis protocol discharge criteria


Secondary Outcome Measures:
  • Digital and infrared imaging [ 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. ] [ Designated as safety issue: No ]
    Change in lesion area and temperature


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549613

Contacts
Contact: George J. Shaw, MD, PhD 513-558-8098 shawge@ucmail.uc.edu

Locations
United States, Ohio
University of Cincinnati, Dept. of Emergency Medicine Recruiting
Cincinnati, Ohio, United States, 45267
Contact: D.Beth Wayne, RN,JD     513-558-8490     waynedb@ucmail.uc.edu    
Contact: Greg Fermann, MD     513-558-8102     fermangj@ucmail.uc.edu    
Principal Investigator: George J Shaw, MD,PhD            
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: George J. Shaw, MD, PhD University of Cincinnati, Dept. of Emergency Medicine
  More Information

No publications provided

Responsible Party: George Shaw, Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01549613     History of Changes
Other Study ID Numbers: 11-11-03-06
Study First Received: February 8, 2012
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cellulitis
Emergencies
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
 Disease Attributes
Skin Diseases
Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013