Extrait

Background and study aims Eczema is a common, debilitating skin condition in children that causes dryness and itching. Everyone naturally has bacteria on their skin, though one called Staphylococcus aureus is more frequently found on the skin of children with eczema. These bacteria may make the eczema worse. However, studies of treatments designed to eliminate or reduce Staphylococcus aureus have been unclear. It is unknown whether children consulting a general practitioner with eczema which is suspected to be infected will benefit from antibiotic treatment. Furthermore, we do not know if taking an antibiotic by mouth or using an antibiotic cream on the skin is better. The aim of this study is to answer the following question: does the addition of oral or topical antibiotic treatment to treatment with corticosteroid cream, reduce eczema severity in children with infected eczema in primary care? Who can participate? Children aged 3 months to less than 8 years with suspected infected atopic eczema. What does the study involve? Children suitable for the study are identified by doctors (General Practitioners). If the child’'s parent/carer agrees, children are randomly put into one of three treatment groups (for one week): oral antibiotic and placebo (dummy) cream; oral placebo and antibiotic cream; oral placebo and placebo cream. Children taking part are followed-up over 12 months. A trained research nurse visits each child during the first 4 weeks and uses questionnaires to assess the severity of eczema, quality of life, healthcare consultations and impact on the family, and take swabs from the skin, nose and mouth. The child’'s parent/carer is asked to complete a diary during the first 4 weeks to record symptom severity and use of medication. After 3 and 12 months the parent/carer is asked to complete questionnaires and repeat the swabs. These swabs are used to assess the impact of treatments on bacterial resistance; to determine the relationship between antibiotic use and subsequent development of antibiotic resistance; and to measure the antibiotic sensitivity of bacteria found on the skin, nose and mouth. What are the possible benefits and risks of participating? The participant and their parent/carer(s) will receive additional advice and support from the study nurse about caring for eczema and using standard eczema treatments (emollient moisturisers and steroid creams). The nurse will also monitor the participating child’'s health over the first four weeks. In addition, the parent/carer(s) will be helping us answer questions about the treatment of eczema in children that should result in better care for children with eczema in the future. As a token of appreciation for their time spent participating in the study, we will give participants a total of £20 in gift vouchers during the study (£10 at the start of the study, £5 at 3 months and £5 at 12 months). Taking part in the study will mean that participants and their parent/carer(s) will give up some of their time. There is a chance that the participating child might develop side effects from the study medication. However, the antibiotics used in this study are the same types of antibiotics GPs prescribe every day to treat infected eczema, and the risk of side effects will be no greater than normal. Side effects are uncommon with these medications, and are not usually serious. More details of the study medication will be provided at the time the research nurse shows the parent/carer(s) how to give their child their medication. Whether or not eligible children enter this study, there is a chance that their eczema may get better or worse. Where is the study run from? The CREAM study will be lead by the South East Wales Trials Unit, Cardiff University in collaboration with the University of Dundee and University of Bristol. When is the study starting and how long is it expected to run for? It is anticipated that recruitment will start autumn 2012. It is hoped each participant will be enrolled on the study for 12 month from recruitment; however, the study will run for a total of 3 years. Who is funding the study? Health Technology Assessment Programme (HTA) (UK) Who is the main contact? Dr Inaam-ul Haq [email protected]

Critère d'inclusion

• Infected Eczema

Liens

• ictrp
• isrctn