Penicillin for the Emergency Department Outpatient Treatment of CELLulitis
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
The main objective of this study is to investigate the non-inferiority of oral flucloxacillin
alone compared with a combination of oral flucloxacillin and phenoxymethylpenicillin for the
emergency department directed outpatient treatment of cellulitis, wound infections and
abscesses, recently renamed by the Food and Drug Administration (FDA) as acute bacterial skin
and skin structure infections (ABSSSIs). Half of the trial participants will receive
flucloxacillin and placebo in combination, and the remaining half will be treated will
flucloxacillin and phenoxymethylpenicillin.
In a secondary objective the trial aims to measure adherence and persistence of trial
patients with outpatient antibiotic therapy. In addition a within-trial evaluation of the
cost per quality adjusted life year (QALY) gained from the use of oral flucloxacillin
compared with combination therapy from the perspective of the health-care payer (direct
costs) the patient and government. Finally the study will externally validate the Extremity
Soft Tissue Infection-score, a Health Related Quality of Life (HRQL) questionnaire designed
to quantify the impact of cellulitis, wound infections and abscesses on patient HRQL in
clinical trials.