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

Management of acute Ear Discharge in Children (MEDIC): a feasibility study

Registry ID
ISRCTN22413988
Source registry
ISRCTN
Status
Not yet recruiting
Phase
PHASE3
Study type
INTERVENTIONAL
Sponsor
Manchester University NHS Foundation Trust
Enrollment
60
Start date
2026-09-30
Completion date
2027-09-30
Last update
2026-08-17

Conditions

Summary

Acute otitis media with discharge

Detailed description

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

Interventions

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

Exclusion criteria

1. Signs of sepsis (requiring hospitalisation) 2. Complications of ear infections (for example mastoiditis, facial nerve palsy, brain abscess, meningitis) 3. Significant immunosuppression 4. Known grommet in the affected ear 5. Known cholesteatoma in the affected ear 6. Allergy to ciprofloxacin 7. Allergy to both amoxicillin and clarithromycin 8. Currently participating in an ear related research study

Locations

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