Uncomplicated Outpatient Cellulitis Clinical Trial
Official title:
Predictors of Failure of Empiric Outpatient Antibiotic Therapy in Emergency Department Patients With Uncomplicated Cellulitis.
| Verified date | October 2013 |
| Source | Lawson Health Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Observational |
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 cellulitis will be evaluated and
compared to treatment failures, thus providing data on successful treatment regimens.
Conclusions: Results from this research may be used to generate a clinical prediction rule
to assist clinicians in effectively treating patients presenting to emergency departments
with cellulitis. Understanding which patient risk factors for treatment failure will assist
clinicians in determining which patients will benefit from intravenous versus oral
antibiotics.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | December 2011 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Adult patients (= 18 years) whose chief complaint was consistent with
a skin or soft tissue infection (key words included cellulitis, abscess, infection, insect
bite, ulcer, or rash) were screened for eligibility by ED staff or trained research
assistants and invited to participate in this study once an emergency physician confirmed
a cellulitis infection. Exclusion Criteria: Patients were excluded if they were currently taking or had been recently treated with antibiotics for the cellulitis prior to presenting to the ED, if they were admitted to hospital, had an abscess only, were cognitively impaired or did not read or speak English. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | The University of Western Ontario | London | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Lawson Health Research Institute | University of Western Ontario, Canada |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | risk factors independently associated with failure of empiric outpatient antibiotic therapy in ED patients with uncomplicated cellulitis. | 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. | 16 months | No |
| Secondary | antibiotic prescribing practices for uncomplicated cellulitis at our institution. | Secondary objectives were to describe the antibiotic prescribing practices for uncomplicated cellulitis at our institution. | 16 months | No |