Acute otitis media with ear discharge MedDRA version: 20.0 Level: LLT Classification code 10033080 Term: Otitis media acute NOS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: BACICOLINE-B®
Pharmaceutical Form:
Trade Name: Amoxicillin
Pharmaceutical Form: Capsule
Trade Name: Amoxicillin
Pharmaceutical Form: Concentrate for oral suspension
Sponsors
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Eligibility
Sex/Gender
All
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 (= 7 days duration) and either parent-reported ear pain in the previous 24 hours or fever (child’s body temperature of = 38.0°C in the previous 24 hours as reported by parents or as measured by the GP during consultation) or both. Are the trial subjects under 18? yes Number of subjects for this age range: 350 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: Are antibiotic-corticosteroid eardrops non-inferior to oral antibiotics in children aged 6 months to 12 years visiting their GP with acute otitis media with discharge due to a spontaneous perforation of the eardrum (AOMd) and ear pain and/or fever, in terms of the proportion of children without ear pain and fever at day 3 (72 hours after randomisation)?;Secondary Objective: 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.;Primary end point(s): The proportion of children without ear pain and fever at day 3. ;Timepoint(s) of evaluation of this end point: Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: 3 days, 2 weeks, 3 months | — |
Countries
Netherlands
Contacts
Public Contactstudy physician
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
Outcome results
None listed