Title: The CREAM Study - Children with Eczema Antibiotic Management study
Funder: Division for Social Care and Health Research (Wales)

Abstract: DESIGN: Double blinded 3-arm randomised controlled trialSETTING: Primary careTARGET POPULATION: Children aged 1 month to less than 5 years with atopic eczema that is suspected by their primary care clinician to be infectedHEALTH TECHNOLOGIES BEING ASSESSED: Oral antibiotics (flucloxacillin or erythromycin if penicillin allergic) and topical antibiotic cream (fusidic acid) both prescribed for one week. Active treatments will be assessed against placebos (see study flow diagram) and all patients will receive topical Eumovate (for trunk or limbs) and / or topical hydrocortisone 1% (for face).MEASUREMENT OF COSTS AND OUTCOMES: Participants will be assessed at baseline 1 week 2 weeks 4 weeks 3 months and 12 months. The primary outcome will be an assessment of subjective severity at two weeks as measured using the validated Patient-Oriented Eczema Measure (POEM). The POEM is based on symptoms over the previous week and therefore will be measuring symptom severity during the week following the end of experimental treatment the period when a treatment effect is most likely. In addition to POEM scores the following outcomes will be measured at baseline 2 weeks 4 weeks and 3 months; quality of life (using the validated Infants Dermatitis Quality of Life (IDQoL) instrument) impact on the child’s family (using the validated Dermatitis Family Impact scale) objective eczema severity (using the Eczema Area and Severity Index (EASI) and a preference-based health measure for the cost utility analysis. We will also measure: daily symptoms medication use adverse effects and healthcare consultations during the first four weeks using a carer-completed diary study medication use through collection of unused study medication at 1 week carers’ preference for treatment standardised clinical photographs at baseline (to aid in the detection of features associated with response to treatment and confirm diagnosis) consultations and antibiotic use for eczema over 12 months (from practice records) and swabs of suspected infected eczema at baseline 2 weeks 3 months and 12 months to identify S. aureus or Group A Streptococcus infection nasal swabs for S. aureus carriage and oral swabs to identify colonisation with Group A Streptococcus and determine any change in frequency of penicillin or macrolide resistance in commensal flora. Costs will be assessed using a societal perspective. Carer borne costs including time off work and purchases of over-the-counter medicines and dressings will be collected via additional questions to carers at the 4 week and 3 month follow-up points. Use of primary and secondary care resources including primary care consultations accident and emergency attendances inpatient admissions and outpatient visits will be assessed by extracting GP records at 12 months.SAMPLE SIZE: Assuming a clinically important difference of 3 on the POEM score we have estimated a meaningful effect size of 0.4. The main analysis will be a comparison of each active treatment with placebo. Therefore using a significance of 0.025 (to allow for two comparisons) with 90% power we would need 135 per group (total 405). Allowing for 20% loss to follow-up we aim to recruit 510 participants (170 per centre).


Research activity codes: 5.1 PHARMACEUTICALS
Health categories: SKIN