Clinical Trial: Predictors of Oral Antibiotic Treatment Failure in Emergency Department Patients With Cellulitis

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

Official Title: Prevalence and Predictors of Initial Oral Antibiotic Treatment Failure in Adult Emergency Department Patients With Cellulitis: a Pilot Study

Brief Summary:

The term cellulitis is a medical term describing a bacterial infection of the skin and tissues beneath the skin. Although it is usually easily treated with antibiotics given either orally or through a vein (intravenously), knowing which route of antibiotic treatment to prescribe to a person attending an Emergency Department with cellulitis is not clear.

A Clinical Prediction rule (CPR) is a decision-making tool that comes from original research as opposed to the opinion of experts. We intend to create a preliminary CPR to decide which patients require oral and which patients require intravenous antibiotics for cellulitis from their first visit to an emergency department. The aim of this is to provide safer care by reducing the risk of a patient returning to the hospital with a worsening infection. It will also promote more cost-effective care by reducing hospital re-attendance rates and wasted antibiotics.

Patients attending the department with cellulitis who are suitable for oral antibiotic treatment will be enrolled into this study. A separate doctor will re-examine at least 10% of study participants in order to reduce bias. A set of physical signs and symptoms will be recorded from each patient in order to determine which ones are associated with them "failing" prescribed oral treatment. A study investigator will then phone the patient after 14 days to see whether they are better or whether they required intravenous antibiotics to get better.


Detailed Summary:
Sponsor: Royal College of Surgeons, Ireland

Current Primary Outcome: Treatment failure [ Time Frame: 2 weeks post commencement of oral treatment ]

The primary outcome is the proportion of patients initially commenced on oral antibiotics who subsequently require IV antibiotics to achieve treatment response. This will be assessed by means of telephone follow-up performed at 14 days post enrolment into the study. Treatment failure is defined as attendance at a treating Emergency Department for intravenous antibiotic therapy if already commenced on oral therapy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Treatment failure - change in type or dose [ Time Frame: 2 weeks ]

    Treatment failure measured by change in prescribed oral antibiotic to another oral antibiotic.

    Treatment failure measured by change in prescribed dose of oral antibiotic to a higher dose of the same antibiotic

  • Inter-observer reliability for candidate predictor variables [ Time Frame: At enrolment ]
    Assessment of inter-observer reliability for the candidate predictor variables listed. This will be performed in at least 10% of patients enrolled into the study by a second recruiting clinician.
  • Loss to follow up [ Time Frame: 2 weeks ]
    Assessment of the loss to follow-up rate and usefulness of the data collection proforma in the pilot study will also prove valuable for planning for the live study.


Original Secondary Outcome: Same as current

Information By: Royal College of Surgeons, Ireland

Dates:
Date Received: August 29, 2014
Date Started: March 2015
Date Completion:
Last Updated: January 25, 2017
Last Verified: January 2017