Topical or oral antibiotics for children with acute otitis media presenting with ear discharge?*

Phase 4

Completed

Conditions: Acute Otitis Media with ear discharge
Acute Suppurative Otitis Media
10027584
10019815

Registration Number: NL-OMON52979

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

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.

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the proportion of children without ear pain and fever at<br /><br>day 3. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are ear pain intensity/severity; fever intensity/severity;<br /><br>ear discharge; time to resolution of total symptoms, persistent eardrum<br /><br>perforation; middle ear effusion; adverse events; disease-specific quality of<br /><br>life; antibiotic consumption; AOM recurrences; costs and cost-effectiveness;<br /><br>antimicrobial resistance.</p><br>