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

NCT01549613 | Completed Phase 4 Results DMC

• 1 other identifier: 11-11-03-06
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Cellulitis; Skin Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

standard treatment with daptomycin

ACTIVE COMPARATOR

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

standard treatment of vancomycin

ACTIVE COMPARATOR

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

Interventions

Daptomycin 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 with daptomycin

Vancomycin 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.

standard treatment of vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to RDTC to the Cellulitis Protocol
• yrs old or greater
• Able and willing to give informed consent
• Hemodynamically stable (systolic blood pressure \>90mmHg and heart rate \<120 beats per minute)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati, Dept. of Emergency Medicine

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Cellulitis

Interventions

Daptomycin; Vancomycin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Glycopeptides; Glycoconjugates; Carbohydrates

Results Point of Contact

• Title: George J. Shaw, MD, PhD
• Organization: University of Cincinnati, Dept. of Emergency Medicine

shawge@ucmail.uc.edu

513-558-8098

Study Officials

• George J. Shaw, MD, PhD

  University of Cincinnati, Dept. of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: March 9, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 1, 2014
• Results First Posted: August 1, 2014

Record last verified: 2014-07

Locations

US (1)