Is treatment with eardrops as good as oral treatment for children with acute otitis media presenting with ear discharge?

Phase 1

• Conditions: Acute otitis media with ear discharge; MedDRA version: 20.0Level: LLTClassification code 10033080Term: Otitis media acute NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2017-000332-34-NL
• Lead Sponsor: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-27
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified