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

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

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.

Study Overview

• Status: Completed
• Conditions: Cellulitis

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Emergency Department Beaumont Hospital
  • Dublin, Ireland
    • Mater Misericoridiae University Hospital
  • Dublin 15, Ireland
    • Connolly Hospital Banchardstown

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged >16 years attending the ED with cellulitis as the primary diagnosis will be consecutively recruited. Only patients who are deemed suitable for an oral antibiotic will be enrolled. Patients who require IV therapy will not be enrolled. Cellulitis may arise de novo, or from a recognised cause such as a wound or ulcer. In order to generate an externally valid clinical prediction rule, we will include all patients attending the ED with cellulitis, including those who may have already been commenced on oral antibiotics (for example, by their general practitioner).

Description

Inclusion Criteria:

• Age >16 years
• Suitable for treatment with flucloxacillin 500mg -1gram qds monotherapy or a suitable alternative for penicillin allergic patients as listed in the local prescribing guidelines.
• Appearance of typical, plaque-like area of erythema over any body part excluding the perineum within the preceding 5 days with any 2 of the following signs:
• 1.Increased warmth over affected area
• 2.Swelling of affected area
• 3.Pain over affected area
• 4.Regional lymphadenopathy

Exclusion Criteria:

• Requirement for IV antibiotics as decided by the treating clinician.
• Age less than 16 years.
• No telephone or access to a telephone.
• Abscess alone without co-existing signs of cellulitis
• Mammalian bite wounds.
• Infected diabetic foot ulcer
• Necrotising soft tissue infections.
• Perineal cellulitis.
• Suspected septic arthritis or osteomyelitis.
• Decubitus ulcers.
• Bilateral cellulitis (as this entity rarely exists).
• Acute lipodermatosclerosis.
• Acute dermatitis.
• Venous stasis dermatitis.
• Deep vein thrombosis.
• Pregnancy.
• Cognitive impairment.
• Any patient who through language barrier or diminished capacity is unable to understand the scope of the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Oral antibiotic therapy; Consecutive adult patients attending the study Emergency Departments with cellulitis will be considered eligible for recruitment to the study. Only those patients deemed suitable for oral antibiotic therapy and planned for discharge will be recruited to the study. Oral antibiotic therapy prescribed will be dependent on local institutional prescribing guidelines. For the purposes of the sites enrolling participants, the antibiotic of choice is oral flucloxacillin 500 milligrams four times daily for seven days. We will be assessing the treatment failure rate for this cohort of patients; namely, the number of patients requiring the primary outcome (change from oral to intravenous antibiotic therapy). We will also assess this group of patient for the secondary outcomes listed above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure	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.	2 weeks post commencement of oral treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure - change in type or dose	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	2 weeks
Inter-observer reliability for candidate predictor variables	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.	At enrolment
Loss to follow up	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.	2 weeks

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Investigators: Principal Investigator: Abel Wakai, MD FRCS FCEM, Royal College of Surgeons, Ireland

Publications and helpful links

General Publications

• Quirke M, Mitchell N, Varley J, Kelly S, Boland F, Moughty A, McKeever J, Fahey T, Wakai A. Prevalence and predictors of oral to intravenous antibiotic switch among adult emergency department patients with acute bacterial skin and skin structure infections: a pilot, prospective cohort study. BMJ Open. 2020 Aug 30;10(8):e034057. doi: 10.1136/bmjopen-2019-034057.
• Quirke M, Boland F, Fahey T, O'Sullivan R, Hill A, Stiell I, Wakai A. Prevalence and predictors of initial oral antibiotic treatment failure in adult emergency department patients with cellulitis: a pilot study. BMJ Open. 2015 Jun 25;5(6):e008150. doi: 10.1136/bmjopen-2015-008150.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 27, 2016
• Study Completion (Actual): September 27, 2016

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: August 29, 2014
• First Posted (Estimate): September 3, 2014

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Clinical Prediction Rule; Cohort Study,; Cellulitis,; Skin and Soft Tissue Infection,; Emergency Department,
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Disease Attributes; Connective Tissue Diseases; Skin Diseases, Infectious; Suppuration; Emergencies; Cellulitis
• Other Study ID Numbers: 14/53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED