Oral flucloxacillin alone versus flucloxacillin and phenoxymethylpenicillin for the emergency department outpatient treatment of cellulitis: a non-inferiority randomised controlled trial

Acute bacterial skin and skin structure infections (ABSSSIs) are commonly encountered in Emergency Departments (EDs). In Ireland, the most common ABSSSI is cellulitis, which is a spreading bacterial infection of the skin and tissues beneath the skin. Approximately 12 in every 1,000 ED patient attendances in Ireland is due to cellulitis. This roughly translates to 1-2 attendances per day in an ED seeing 40,000 new patients per year. This group of infections therefore represents a serious healthcare and societal burden. Despite this burden, the antibiotic treatment of cellulitis and impact it has on patients' quality of life and economic circumstances has not previously been studied in Ireland.
The most commonly prescribed antibiotics for cellulitis in Ireland, the United Kingdom and many parts of Europe are called flucloxacillin and phenoxymethylpenicillin. Current evidence reveals that for patients discharged home from EDs on antibiotic treatment, doctors prescribe antibiotics in a disparate fashion: both antibiotics are prescribed together in one-third; flucloxacillin alone in one-third; and a variety of other antibiotics to the remaining one-third. Hospital prescribing guidelines are also contradictory and evidence from published textbooks and research papers show widespread practice variation with no agreed consensus.
We aim to perform a randomised controlled trial (RCT) comparing oral flucloxacillin and placebo to oral flucloxacillin and phenoxymethylpenicillin for the treatment of cellulitis, thus providing definitive evidence to address this disparate prescribing practice. We also aim to provide important information about how cellulitis affects a patient's quality of life, the usefulness of a specially designed quality-of-life instrument for patients with cellulitis, the economic impact of cellulitis on patients, and finally, how well patients adhere to their prescribed antibiotic treatment. We have created a unique collaboration of researchers in order to provide much needed evidence to guide doctors treating this relatively common but understudied condition.

Award Date
23 October 2015
Award Value
Principal Investigator
Dr Abel Wakai
Host Institution
Royal College of Surgeons in Ireland
Health Research Awards - Definitive Interventions