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

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ClinicalTrials.gov Identifier: NCT01972646
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : October 30, 2013
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Shelley McLeod, Lawson Health Research Institute

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 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.


Condition or disease
Uncomplicated Outpatient Cellulitis

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Failure of Empiric Outpatient Antibiotic Therapy in Emergency Department Patients With Uncomplicated Cellulitis.
Study Start Date : June 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Group/Cohort
Adult patients (≥ 18 years) with uncomplicated cellulitis
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972646


Locations
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Canada, Ontario
The University of Western Ontario
London, Ontario, Canada, N6A5W9
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
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Principal Investigator: Andrew McRae, MD, FRCPC, PhD University of Western Ontario, Canada

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Responsible Party: Shelley McLeod, Research Program Manager, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01972646     History of Changes
Other Study ID Numbers: 16936e
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Shelley McLeod, Lawson Health Research Institute:
Cellulitis, treatment failure, skin and soft tissue infections, risk factors.

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Cellulitis
Emergencies
Disease Attributes
Pathologic Processes
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation