Medical Student Research Fellowship for Summer 2009

Mentor: Monica I. Ardura, DO, Clinical Instructor Pediatrics
Department: Pediatrics, Division of Infectious Diseases
Room number: G3.208
Mail Code: 9063
Phone number: 214-648-3720 or 214-648-7587
E-mail: monica.ardura@utsouthwestern.edu
Project title: Antimicrobial Therapy for Outpatient Management of Community-
Acquired Methicillin-resistant Staphylococcus aureus Skin and Soft-
tissue Infections in Children

Human subjects IRB approved project number (where applicable): 112005-046 (currently under continuing review)

Animal subjects IRB approved project number (where applicable): N/A

Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects)
Patient-based clinical research

Brief Description of Project:
Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) has emerged as a major pathogen in children, most commonly manifesting as skin and soft-tissue infections (SSTI). Some studies have found that incision and drainage of the abscess may be all that is needed to achieve a clinical cure, while other retrospective studies have found that patients who received antibiotics did better than those that did not. Given lack of consistency in disease severity, antibiotic regimens, and clinical endpoints, the data is inconclusive and the optimal outpatient management of CA-MRSA SSTIs is still unknown.

In this study, subjects presenting to the Emergency Department (ED) at Children's Medical Center of Dallas with a skin and soft-tissue infection requiring drainage will have an ultrasound performed, undergo incision and drainage, and have a bacterial culture obtained by ED staff. Subjects will then be randomized to receive an anti-staphylococcal antibiotic or no antibiotic. The primary endpoint is clinical improvement (as defined in the study protocol) at the 48-72h ED follow-up visit in each group. Secondary endpoints include antibiotic side effects, new SSTI, and 'disease free' interval at 1 and 3 months post study enrollment.

Medical students who are interested in contributing to this study should know that responsibilities include: screening and enrolling of potential subjects, collection of demographic and clinical data from the electronic and paper medical records, phone follow-ups, database input, and data analysis. Students who wish to participate must complete the prerequisites for research credentialing at CMCD (checklist attached). Students who participate in the study will be part of the final manuscript.

Previous Research Activities or Publications with Medical Students: This is my first request.