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

NCT ID: NCT01549613

Last Updated: 2014-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-07-31

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.

Conditions

Cellulitis; Skin Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Daptomycin

Intervention Type: DRUG

• 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.

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.

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

• 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

George Shaw

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George J. Shaw, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati, Dept. of Emergency Medicine

Locations

University of Cincinnati, Dept. of Emergency Medicine

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

11-11-03-06

Identifier Type: -

Identifier Source: org_study_id