No registrations found.
ID
Source
Brief title
Health condition
acute otitis media in general practice, antibiotics, placebo, infants
acute middenoorontsteking in huisartsenpraktijk, antibiotica en placebo, kinderen onder de 2 jaar.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Persistent symptoms at day 4, assessed by the doctor and defined as persistent earache, fever, crying or being irritable
Secondary outcome
- Clinical treatment failure at day 11
- Duration of fever or/of pain/crying
- The mean number of doses of analgesics given
- The percentage of children with middle ear effusion at 6 weeks, 3 months and 6 months
- Adverse effects
Background summary
This trial was planned to see what the effectiveness was of antibiotic treatment in childeren under 2 years of age with acute otitis media in general practice. 7-8 children in this age-group needed to be treated with antibiotics to improve symptomatic outcome at day 4 in one child.
Study objective
Antibiotics might have more effect in the children less than 2 years of age.
Study design
Evaluation at 4 days, 11 days, 6 weeks, 3 months and 6 months.
Further first 10 days a diary.
Intervention
Amoxicillin suspension 40mg/kg/day in three divide doses for 10 days or placebo suspension.
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
3. Compromised immunity
4. Craniofacial abnormalities
5. Down's syndrome
6. Being entered in this study before.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1365 |
| NTR-old | NTR1426 |
| Other | : METC, UMC Utrecht: I93-63 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Summary results
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- 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.
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- 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.
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- 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.