A randomised placebo-controlled trial of oral and topical antibiotics for children with clinically infected eczema in the community: the ChildRen with Eczema, Antibiotic Management (CREAM) study

• DOI: 10.3310/hta20190
• Publication Date: 2016-03-03T09:15:23Z
• Authors: Nick A Francis; Matthew J Ridd; Emma Thomas-Jones; Victoria Shepherd; Christopher C Butler; Kerenza Hood; Chao Huang; Katy Addison; Mirella Longo; Charis Marwick; Mandy Wootton; Robin Howe; Amanda Roberts; Mohammed Inaam-ul...; Vishnu Madhok; Frank Sullivan
• Keywords: staphylococcus aureus; Staphylococcus aureus; RJ; Administration, Topical; Cost-Benefit Analysis; RL; NDAS; oral antibiotics; Eczema; 610; Administration, Oral; Research Support; Severity of Illness Index; 03 medical and health sciences; 0302 clinical medicine; topical antibiotics; Double-Blind Method; Journal Article; Medical technology; Humans; R855-855.5; Non-U.S. Gov't; Child; R2C; Randomised controlled trial; Research Support, Non-U.S. Gov't; ~DC~; RJ Pediatrics; Infant; Oral antibiotics; infection; United Kingdom; Anti-Bacterial Agents; 3. Good health; Infeciton; Child, Preschool; Quality of Life; eczema; BDC; randomised controlled trial; Topical antibiotics

Background Secondary skin infection is common during eczema exacerbations and many children are treated with antibiotics when this suspected, although there little high-quality evidence to justify practice. Objective To determine the clinical effectiveness of oral topical antibiotics, in addition standard treatment emollients corticosteroids, clinically infected eczema. Design Multicentre randomised, double-blind, placebo-controlled trial. Setting General practices dermatology clinics England, Wales Scotland. Participants Children (aged 3 months < 8 years) a diagnosis (according U.K. Working Party definition) suspicion infection. Interventions (1) Oral flucloxacillin placebo; (2) fusidic acid (Fucidin ® , Leo Laboratories Limited) (3) placebos, all for 1 week. Main outcome measures Patient-Orientated Eczema Measure (POEM) at 2 weeks (assessing subjective severity week following treatment). Results We randomised 113 (36 antibiotic, 37 antibiotic 40 placebo), which was fewer than our revised target sample size 282. A total 103 (92.0%) had one or more features suggestive 78 (69.6%) Staphylococcus aureus cultured from swab. resulted 1.52 [95% confidence interval (CI) –1.35 4.40] 1.49 (95% CI –1.55 4.53) increase (worse severity) POEM score weeks, relative placebo controlling baseline score. Area Severity Index (objective scores were also higher (worse) intervention groups, 0.20 –0.12 0.52) 0.42 0.09 0.75) respectively, weeks. Analyses impact on family, quality life, daily symptom scores, longer-term outcomes consistent finding no limited difference trend towards worse groups. Sensitivity analyses, including adjusting compliance imputation missing data, main findings. Conclusions Our data suggest that have effect, harmful community. The CIs around estimates exclude meaningful beneficial effect (published minimal important 3.4). Although most patients trial S. their skin, participants primarily mild–moderate those signs severe often excluded. Clinicians should consider avoiding use suspected community who do not ‘severe infection’. Further research seek understand how best encourage steroids limit flares without infection, as well developing tools better phenotype flares, order define population may benefit treatment. Trial registration European Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2011-003591-37 Current Controlled ISRCTN96705420. Funding National Institute Health Research Technology Assessment programme.