The CREAM Study:? ChildRen with Eczema, Antibiotic Management Study: a randomised controlled trial

Cardiff University (UK)0 个研究点目标入组 510 人开始时间: 2012年6月27日最近更新: 2019年8月26日

适应症

试验速览

•Children (aged 3 months to less than five years) with atopic eczema (as defined by UK working party criteria) who are presenting in primary care and their treating clinician suspects infected eczema because of at least one of the following:
•The UK working party criteria state that in order to qualify as a case of atopic eczema with the UK diagnostic criteria, the child MUST have:
•1. An itch skin condition in the last 12 months
•2. And three or more of the following:
•2.1. Onset below age 2 (Not used in children under 4 years old)
•2.2.History of flexural involvement.
•2.3. History of general dry skin atopic disease (In children aged under 4 years old, history of atopic disease in a first degree relative may be included)
•2.4. Personal history of other atopic disease
•3. The eczema is failing to respond to standard treatment
•4. There is a flare in the severity or extent of the eczema
•5. There is weeping, crusting, or pustules

•1. Use of oral or topical antibiotics in the past week
•2. Use of potent (Betamethasone valerate 0.1%, Betacap, Betesil, Bettamousse, Betnovate, Cutivate, Diprosone, Elocon, Hydrocortisone butyrate, Locoid, Locoid Crelo, Metosyn, Nerisone, Synalar, Aureocort, Betnovate-C, Betnovate-N, Fucibet, Lotriderm, Synalar C, Synalar N, Diprosalic) or very potent (Clarelux, Dermovate, Etrivex, Nerisone Forte, Dermovate-NN) corticosteroids within the past week
•3. Immune suppression
•4. Features suggestive of eczema herpeticum (significant pain, punched out lesions)
•5. Severe infection (systemic upset, cellulitis) ) and/or suspected infection warrants immediate hospitalisation or urgent dermatology referral
•6. Severity of eczema
•7. Known renal and / or hepatic impairment
•8. Allergy to penicillin and erythromycin or allergy to penicillin and contraindication to erythromycin, such as current use of medication that is known to interact with erythromycin
•9. Allergy the fusidic acid
•10. Current use of any medication that is known to interact with fuscidic acid
•11. Extensive eczema (EASI score ? 40 [equates to moderately severe eczema affecting 80% of body surface area])

发起方

Cardiff University (UK)