Clinical Trial: Predictors of Failure of Empiric Outpatient Antibiotic Therapy in Emergency Department Patients With Uncomplicated Cellulitis.

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Predictors of Failure of Empiric Outpatient Antibiotic Therapy in Emergency Department Patients With Uncomplicated Cellulitis.

Brief Summary:

Introduction: Despite several expert panel recommendations and cellulitis treatment guidelines, there are currently no clinical decision rules to assist clinicians in deciding which emergency department (ED) patients should be treated with oral antibiotics and which patients require intravenous therapy at first presentation of uncomplicated cellulitis. The objective of this prospective study is to determine potential patient risk factors associated with adult patients (>17years) presenting to the ED with a concern about a skin or soft tissue infection who fail initial antibiotic therapy for the treatment of standard cellulitis and require a change of antibiotics or admission to hospital.

Methods: This study will be a prospective study conducted in two tertiary care EDs. Patients will be excluded if they have been treated with antibiotics for the current bout of cellulitis prior to presenting to the ED, patients admitted to hospital and those patients with abscesses only. Hired research assistants (RAs) will administer a questionnaire at the initial ED visit with telephone follow-up 2 weeks later. Treatment failure will be defined as patients requiring subsequent hospitalization, initiation of intravenous antibiotics (if oral antibiotics were prescribed initially), or a change of oral antibiotics for the original cellulitis.

Results: This study will provide a detailed profile of patient risk factors associated with treatment failure of cellulitis. The results will be analyzed and used in formulating a clinical decision rule for effective treatment of cellulitis presenting to the ED. Each of the predictor variables associated (p ≤ 0.1) with failed treatment in the univariate analysis will be considered in a multivariate logistic regression model. Additionally, treatment variability among clinicians in regard to cell

Detailed Summary:
Sponsor: Lawson Health Research Institute

Current Primary Outcome: risk factors independently associated with failure of empiric outpatient antibiotic therapy in ED patients with uncomplicated cellulitis. [ Time Frame: 16 months ]

The primary objective of this study was to determine risk factors independently associated with failure of empiric outpatient antibiotic therapy in ED patients with uncomplicated cellulitis.


Original Primary Outcome: Same as current

Current Secondary Outcome: antibiotic prescribing practices for uncomplicated cellulitis at our institution. [ Time Frame: 16 months ]

Secondary objectives were to describe the antibiotic prescribing practices for uncomplicated cellulitis at our institution.


Original Secondary Outcome: Same as current

Information By: Lawson Health Research Institute

Dates:
Date Received: October 22, 2013
Date Started: June 2010
Date Completion:
Last Updated: October 24, 2013
Last Verified: October 2013