Acute Otitis Media with ear discharge Acute Suppurative Otitis Media
Conditions
Interventions
Children will be randomly allocated to either 1)
hydrocortisone-bacitracin-colistin (Bacicoline-B®) eardrops, five drops, three
times per day in the discharging ear(s) for 7 days or 2) amoxicillin s
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Children aged 6 months to 12 years whose parents are consulting the GP with AOM and ear discharge in one or both ears (= 38.0°C in the previous 24 hours as reported by parents or as measured by the GP during consultation) or both.
Exclusion criteria
Exclusion criteria: Children will be excluded from participation if they 1. are systemically very unwell and requires immediate oral antibiotics or immediate hospitalization (e.g. child has signs and symptoms of serious illness and/or complications such as mastoiditis/meningitis); 2. are at high risk of serious complications including children with known immunodeficiency other than partial IgA or IgG2 deficiencies, craniofacial malformation such as cleft palate, children with Down syndrome, previous ear surgery other than grommet insertion; 3. have grommets in place; 4. have a pre-existing perforation of the eardrum; 5. had an prior AOM episode (with or without ear discharge) in previous 28 days; 6. used oral antibiotics or topical antibiotics in previous 2 weeks; 7. have a known allergy or sensitivity to oral amoxicillin or hydrocortisone-bacitracin-colistin; 8. have already participated in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the proportion of children without ear pain and fever at day 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are ear pain intensity/severity; fever intensity/severity; ear discharge; time to resolution of total symptoms, persistent eardrum perforation; middle ear effusion; adverse events; disease-specific quality of life; antibiotic consumption; AOM recurrences; costs and cost-effectiveness; antimicrobial resistance. | — |
Countries
Netherlands
Outcome results
None listed