Children with Eczema Antibiotic Management Study (CREAM)

• Research type

  Research Study

• Full title

  Children with Eczema Antibiotic Management Study (CREAM)

• IRAS ID

  88270

• Contact name

  Nicholas Francis

• Sponsor organisation

  Cardiff University, Research and Commercial Division

• Eudract number

  2011-003591-37

• ISRCTN Number

  0000000

• Research summary

  Eczema is a common, debilitating skin condition in children that causes dryness and itching. Everyone naturally has bacteria on their skin, and a bacterium 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. CREAM is a double-blind, randomised controlled trial based in general practices in Wales, Scotland, and the West of England. Children suitable for the study will be identified by General Practitioners. If the child??s parent/carer agrees, children will be randomly put into one of three treatment groups (for one week): 1. Oral antibiotic and placebo cream; 2. oral placebo and antibiotic cream; or 3. oral placebo and placebo cream. Children taking part will be followed-up over 12 months. A trained research nurse will visit each child during the first 4 weeks and use established questionnaires to assess the severity of eczema; effect on quality of life; healthcare consultations; impact on the family; and take swabs from the skin, nose and mouth. The child??s parent/carer will be asked to complete a diary during the first 4 weeks to record symptom severity and use of medication. At 3 and 12 months, the parent/carer will be asked to complete questionnaires and repeat swabs. These swabs will be used to assess impact of treatments on subsequent development of antibiotic resistance; and to measure the antibiotic sensitivity of bacteria found on the skin, nose and mouth.

• REC name

  Wales REC 3

• REC reference

  12/WA/0180

• Date of REC Opinion

  17 Jul 2012

• REC opinion

  Further Information Favourable Opinion