Title
CREAM: ChildRen with Eczema Antibiotic Management Study

Value
£1,333,027 (£709,685 initial now additional funding)

Funder
NIHR HTA

Principal Investigator
Dr Nick Francis

Co-Investigators
Prof Chris Butler, Prof Kerry Hood, Prof Frank Sullivan (University of Dundee), Dr Matthew Ridd (University of Bristol), Prof David Cohen (University of Glamorgan), Dr Manju Kalavala, Dr Robin Howe, Dr Peter Davey, Micaela Gal.

Type of study
RCT

Summary
Eczema is a debilitating skin condition that is especially common in young children. People with eczema frequently have a bacterium called Staphylococcus aureus (S. aureus) on their eczematous skin. Many doctors believe that infection with this bacterium can make eczema worse. However, studies so far of treating patients with eczema to eliminate or reduce S. aureus have been inconclusive and mostly of poor quality. So we do not know whether patients with eczema, which a GP or nurse suspects is infected, will benefit from treatment with antibiotics. Furthermore, we do not know whether taking an antibiotic by mouth (oral) or using an antibiotic cream on the skin (topical) is more effective and/or causes least harm. The primary aim of this study is to determine whether oral or topical antibiotics, in addition to corticosteroid cream, are effective at reducing subjective eczema severity at two weeks in children with suspected infected eczema in primary care. Additional objectives include: To determine the cost-effectiveness of treating suspected atopic eczema with oral or topical antibiotics, in terms of cost per unit reduction in subjective outcome severity. To assess the effectiveness of oral or topical antibiotic treatment on objective eczema severity and dermatitis specific quality of life. To compare oral and topical antibiotic treatments in terms of recovery, short and long-term effects, adverse effects, parent preference, and effect on prevalence of colonisation with resistant organisms. The double-blind three-arm randomised controlled trial will last for 36 months.

Group role / contribution
WSPCR led

Start date
January 2012 

End date
December 2013

Related links
CREAM study website: http://www.cream-study.co.uk/