RABBIT

A trial to investigate the clinical effectiveness of antibiotics over a 12-week treatment period in reducing episodes of Acute Otitis Media in children over a 12-month follow up period.

RABBIT: Recurrent Otitis Media and AntiBIotics Trial

Approximately three-quarters of children in the UK will have had at least one ear infection (Acute Otitis Media; AOM) by the age of five, and many experience repeated infections. Five or more episodes in a year is known as recurrent acute otitis media (rAOM). These infections can significantly affect children and families, causing pain, sleepless nights and time off school and work.

Treatment for rAOM varies and may include monitoring with antibiotics when needed (conservative management), long-term low-dose antibiotics, or surgery to insert grommets. However, there is no recent evidence showing whether long-term antibiotics are more effective than conservative management or which antibiotic works best at reducing infections.

This trial will investigate whether long-term low-dose antibiotics are effective, safe and good value for money. Children under eight years with rAOM will be randomly allocated to receive trimethoprim, azithromycin or conservative management for three months.

Parents will record their child’s symptoms using an App or paper diary, and children will be reviewed every three months for 12 months. We will compare the number of further ear infections and antibiotic courses, grommet surgery, quality of life, time off school or work, and use of healthcare services. Parents may also be interviewed about their experiences of the treatments and taking part in the trial.

Parents with experience of caring for a child with rAOM and the GenerationR Liverpool Young People’s Advisory Group helped design the trial and will remain involved throughout.

The trial will establish whether long-term antibiotics are effective for children with rAOM and, if so, which treatment is most effective. The findings could improve care for children and families, reduce unnecessary antibiotic use and antimicrobial resistance, and reduce unnecessary costs to the NHS.