METHODS/DESIGN: In a multicenter, randomized, double-blind, non-inferiority trial, adult patients admitted with
cellulitis will be included.
Cellulitis is defined as warmth,
erythema, and induration of the skin and/or subcutaneous tissue, with or without
pain (including
erysipelas). All patients will initially be treated with intravenous
flucloxacillin, and will be evaluated after 5-6 days. Those who have improved substantially (defined as being afebrile, and having a lower
cellulitis severity score) will be randomized at day 6 between additional 6 days of oral
flucloxacillin (n = 198) or placebo (n = 198). Treatment success is defined as resolution of
cellulitis on day 14 (disappearance of warmth and tenderness, improvement of
erythema and
edema), without the need of additional
antibiotics for
cellulitis by day 28. Secondary endpoints are relapse rate (up to day 90), speed of recovery (using a
cellulitis severity score until day 28, and VAS scores on
pain and swelling until day 90), quality of life (using the SF-36 and EQ-5D questionnaires) and costs (associated with total
antibiotic use and health-care resource utilization up to day 90).
DISCUSSION: Inclusion is planned to start in Q2 2014.
TRIAL REGISTRATION: ClinicalTrials.gov (NCT02032654) and the Netherlands Trial Register (NTR4360).