Every year, tens of thousands of children in the UK visit their GP with a painful ear infection that has burst their eardrum and is leaking fluid. Doctors currently have no strong evidence to tell them whether to prescribe oral antibiotics or antibiotic ear drops, leading to inconsistent treatment. This uncertainty matters because oral antibiotics can cause side effects and contribute to antimicrobial resistance, while ear drops might work just as well with fewer risks. The research team will test whether a full-scale clinical trial comparing these two treatments is even possible. They plan to recruit families, including those from deprived communities and ethnic minority groups, to understand barriers to taking part in research. They will also explore whether parents can reliably give their children ear drops at home. If topical antibiotics prove as effective as oral ones, the impact could be a step-change in practice: fewer adverse reactions, less antimicrobial resistance, and a standardised clinical pathway that reduces NHS costs while improving quality of life for children and their families. The findings will be shared through medical journals, conferences, and public infographics in multiple languages.
View original technical description
Research question Is it feasible to perform a randomised controlled trial comparing oral versus topical antibiotics for the treatment of paediatric acute otitis media with discharge (AOMd)? Background AOMd is caused by an infection behind the ear drum which leads to perforation and resultant leakage of discharge from the ear in children and young people (CYP). In the UK it accounts for over 41,000 primary care appointments each year. AOMd has a significant physical and psychosocial impact on CYP and their families. Currently CYP with AOMd are treated with either oral or topical antibiotics, with the preference being oral antibiotics in primary care and topical antibiotics in secondary care. No strong evidence exists comparing the effectiveness of oral or topical antibiotics, leading to this variation in prescribing practice. If topical antibiotics are shown to be as effective as oral antibiotics, there could be significant benefits by reducing adverse reactions and antimicrobial resistance associated with oral antibiotic use. Aim This study will address the remaining uncertainties from our completed NIHR RfPB funded work (NIHR204036) and produce the necessary building blocks for a successful full-scale RCT to enable the development of an evidenced based clinical pathway for managing paediatric AOMd in primary care. Objectives Develop partnerships with families from deprived communities and minority ethnic groups to assess barriers to research engagement. Determine if an RCT using remote e-consent is feasible to compare oral amoxicillin against topical ciprofloxacin in treating paediatric AOMd in primary care. Understanding enablers and barriers to caregiver delivery of antibiotics. Methods WP1: Partnerships will be developed with deprived families, ethnic minorities, non-profit organisations and community leaders by organising 4 meetings within the community. WP2: A feasibility RCT comparing oral amoxicillin with topical ciprofloxacin for paediatric AOMd will be conducted. Thirty patients per treatment arm will be recruited using a remote trial design. WP3: Within the RCT, participants will be asked about antibiotic adherence related issues. Timelines for delivery Following ethical approval, the feasibility RCT will recruit from 01/06/2026 to 30/11/2026. The results will be analysed, and time will be allocated to write the grant application for the full scale RCT. Anticipated impact and dissemination If topical antibiotics are shown to be as effective as oral antibiotics there could be significant patient benefit by reducing adverse reactions and antimicrobial resistance caused by oral antibiotics leading to a step-change in practice. A best practice clinical pathway will be developed which will result in quality-of-life improvements for children and their families, whilst standardising management, and reducing NHS costs. Engagement with deprived local communities and ethnic minority groups will help to ensure research inclusivity within the full scale RCT and promote generalisaibility of the study findings. Dissemination to the public will be supported by service users to produce a plain language summary and infographic in multiple languages. The results will be presented at medical conferences and published in an open access peer-reviewed medical journal, adhering to the CONSORT statement for feasibility studies.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know