Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01549613
Study type Interventional
Source University of Cincinnati
Contact
Status Completed
Phase Phase 4
Start date May 2012
Completion date July 2013

See also
  Status Clinical Trial Phase
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Completed NCT00746109 - Study of Wound Packing After Superficial Skin Abscess Drainage Phase 4
Completed NCT03296280 - Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
Not yet recruiting NCT01947660 - Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery N/A
Completed NCT01876628 - Adjunctive Clindamycin for Cellulitis: C4C Trial. Phase 4
Active, not recruiting NCT01706913 - Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis N/A
Completed NCT03474523 - Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment N/A
Recruiting NCT03312946 - Effect of Vibro-oscillatory Therapy for Improvement of Body Contour and Appearance of Cellulite. N/A
Active, not recruiting NCT05226260 - Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care N/A
Active, not recruiting NCT03785834 - The Effect of Histopathologic Analysis and Tissue Cultures on Inpatient Management of Cellulitis and Pseudocellulitis
Completed NCT01029782 - Comparison of Intravenous Cefazolin Plus Oral Probenecid With Oral Cephalexin for the Treatment of Cellulitis Phase 2
Completed NCT00676130 - Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients N/A
Not yet recruiting NCT03917134 - Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy N/A
Completed NCT02230813 - Predictors of Oral Antibiotic Treatment Failure in Emergency Department Patients With Cellulitis N/A
Completed NCT01557426 - Soft Tissue Ultrasound of Infections Phase 1
Completed NCT01339091 - Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Phase 3
Completed NCT00984022 - Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage Phase 2
Completed NCT04091672 - RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction N/A
Completed NCT05023200 - The Personalised Antibiotic Duration for Cellulitis (PAD-C) Study
Terminated NCT02087527 - Use of Corticosteroids in Children With Cellulitis N/A