Antibiotics for acute otitis media in children less than 2 years of age.

Completed

• Conditions: acute otitis media in general practice, antibiotics, placebo, infantsacute middenoorontsteking in huisartsenpraktijk, antibiotica en placebo, kinderen onder de 2 jaar.

• Registration Number: NL-OMON26781
• Lead Sponsor: Julius Center for Health Sciences and Primary Care, UMC Utrecht

Brief Summary

Damoiseaux RAMJ, van Balen FAM, Hoes AW, de Melker RA. Antibiotic treatment of acute otitis media in children under two years of age: evidence based? Gr J Gen Pract 1998;48:1861-4. <br><br> - Damoiseaux RAMJ, van Balen FAM, Hoes AW, Verheij TJM, Melker RA. Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years. BMJ 2000;320:350-4. <br><br> - Damoiseaux RAMJ, Sanders LAM, van Balen FAM, Rijkers GT. Sibling history of recurrent acute otitis media correlates with low IgG2 anti-pneumococcal polysaccharide antibody levels. Pediatr Infect Dis J 2000;19:176-7. <br><br> - Damoiseaux RAMJ, van Balen FAM. Duration of clinical symptoms in children under two years of age with acute otitis media. Eur J Gen Pract 2000;6:48-51. <br><br> - Damoiseaux RAMJ, Rovers MM, van Balen FAM, Hoes AW, de Melker RA. Long-term prognosis of acute otitis media in infancy: determinants fo recurrent acute otitis media and persistent middle ear effusion. Fam Pract 2006;23:40-5.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

1. Children aged 6 months to two years with acute otitis media in general practice

Exclusion Criteria

1. Antibiotic treatment in de preceding 4 weeks

2. Allergy to amoxicillin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Persistent symptoms at day 4, assessed by the doctor and defined as persistent earache, fever, crying or being irritable

Secondary Outcome Measures

Name	Time	Method
- Clinical treatment failure at day 11<br /><br>- Duration of fever or/of pain/crying<br /><br>- The mean number of doses of analgesics given<br /><br>- The percentage of children with middle ear effusion at 6 weeks, 3 months and 6 months<br /><br>- Adverse effects