The Runny Ear STudy (REST)
Research type
Research Study
Full title
Immediate oral, immediate topical or delayed oral antibiotics for acute otitis media with discharge (the Runny Ear STudy: REST)
IRAS ID
229293
Contact name
Alastair Hay
Contact email
Sponsor organisation
University of Bristol
Eudract number
2017-003635-10
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Middle ear infections (medical term: 'acute otitis media' or 'AOM') are common painful infections in children. There were 2.8M treatment episodes for AOM in 2011 in England and Wales. Germs multiply in the confined middle ear resulting in a build-up of pressure that stretches the ear drum. In around 1 in 7 children, the ear drum bursts, releasing a liquid (medical term: 'discharge' or 'otorrhoea') that can be seen coming out of the ear. It is commonly believed that the pain of AOM improves when the ear drum bursts, but our research shows the pain is similar, with or without the ear drum bursting.
At the moment nearly all UK children with AOM and discharge (AOMd) seen by their GP/nurse are treated with antibiotics by mouth. These can cause side effect like rashes, diarrhoea and vomiting and more rarely, severe allergic reactions. They can also make the germs in a child’s body resistant to antibiotics.
It may be possible to use alternative treatments for ear discharge. One possibility is to use antibiotic ear drops research has shown these are better than antibiotics by mouth for children with runny ears and grommets, probably because the antibiotics are given directly to the place they are most needed. Another potential treatment is a ‘delayed’ antibiotic prescription (where parents are advised to wait to see if the child’s infection improves without antibiotics). Our studies in other infections suggest this can be just as effective and safe, but with fewer side effects.
REST will be a randomised controlled trial conducted in GP practices in England. We will be recruiting children aged 12 months to 16 years. The trial is funded by the National Institute for Health Research Health Technology Assessment programme.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0181
Date of REC Opinion
23 May 2018
REC opinion
Further Information Favourable Opinion