A study to see how best to treat ear discharge in children

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2026
INTERVENTION: Control arm: Oral Amoxicillin or Clarithromycin. Amoxicillin dosed by age for 7 days. Clarithromycin doses by weight for 7 days. Intervention arm: Ciprofloxacin topical drops. One ampule (0.25ml) of 2mg/ml drops twice daily for 7 days. Follow up for all participants: 14 days Randomisation: individual online tool CONDITION: Acute otitis media with discharge ; Ear, Nose and Throat PRIMARY OUTCOME: Feasibility outcomes:; 1.Number of patients referred to the study during recruitment measured using study database at the end of the study; 2.Time from referral to remote consultation with research doctor measured using study database at the end of the study; 3.Proportion of patients choosing medication collection measured using study database at the end of the study; 4.Time from prescription to medication delivery or collection measured using study database at the end of the study; 5.Proportion of patients randomised of those referred to the study measured using study database at the end of the study; 6.Participant‐reported adherence to treatment measured using study database at the end of the study; 7.Proportion of patients with complete follow‐up data measured using study database at the end of the study; 8.Time to cessation of otorrhoea measured using study database at the end of the study SECONDARY OUTCOME: 1. Time to cessation of ear discharge (otorrhoea) measured using daily text message question response; 2. Resolution of ear discharge measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement; 3. Pain severity measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement; 4. Pain duration measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement; 5. Fever episodes measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement; 6. Sleep disturbance measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement; 7. Appetite disturbance measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement; 8. Complications of infection measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement; 9. Healthcare interactions measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement; 10. Adverse drug reactions measured using questionnaire at day 7 post treatment commencement and day 14 post treatment commencement INCLUSION CRITERIA: 1. Children and young people aged =6 months and <7 years 2. Unilateral or bilateral otorrhoea 3. New episode of otorrhoea (>6 weeks from previous episode) 4. Otorrhoea duration <6 weeks 5. No prior antibiotic treatment for this episode 6. No antibiotics for other reasons within 6 weeks prior 7. Parent/guardian who is able to understand written English, Urdu, Arabic, Punjabi or Polish
Epistemonikos ID: d6c30066e2b8cc25f10f6dd8c22178172b4cbfa7
First added on: Aug 15, 2026