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CREAM

ChildRen with Eczema, Antibiotic Management study

Eczema is a common, debilitating skin condition in young 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. The presence of 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.

Researchers in Cardiff University, led by Dr Nick Francis, are leading a new £1.3M study, funded by the Department of Health's National Institute for Health Research Health Technology Assessment Programme that aims to answer these questions. CREAM is a double-blind, randomised controlled trial based in general practices in Wales, Scotland, and the West of England. Children aged between 3 months and under 8 years old and are 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; 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 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.

The results of this study should lead to immediate benefits for patients. In addition to answering questions about the effectiveness of antibiotic treatments, it will provide valuable data on the diagnosis of infection in children with eczema, the natural history of infected eczema, its impact on quality of life and other patient related outcomes, and the affect of antibiotics on colonisation with resistant organisms.

Study Team

Professor Sullivan, Frank (Director Population Health Sciences, University of Dundee)

Professor Kerry Hood (Cardiff University)

Professor Chris Butler (Cardiff University)

Dr Howe, Robin(Consultant Medical Microbiologist, Public Health Wales NHS Trust)

Professor Cohen, David (Professor of Health Economics, University of Glamorgan)

Dr Kalavala, Manju (Consultant Dermatologist, The Welsh Institute of Dermatology, UHW)

Dr Ridd, Matthew (NIHR Clinical Lecturer, University of Bristol)

Professor Davey, Peter (Lead Clinician for Clinical Quality Improvement, University of Dundee)

Study Management Team:

Dr Thomas-Jones, Emma (Senior Trial Manager, Cardiff University)

Dr Haq, Mohammed Inaam-ul (Trial Manager, Cardiff University)

Dr Kalebic, Natasha (Data Manager, Cardiff University)

Dr Kelly, Mark (Statistician, Cardiff University)

Mr Cossio, Miguel (Database Programmer)

Contact information

Email address
CREAM@Cardiff.ac.uk
Telephone
+44 29 20687665 (CREAM Study Manager)

Key data

Status
Running
Start date
June 1, 2012
End date
May 31, 2015
Grant value
£682,463
General enquiries
Dr Mohammed Inaam-ul Haq
Dr Emma Thomas-Jones
Chief investigators
Dr Nick Francis

External links

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