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


- candidate number3888
- NTR NumberNTR1426
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-aug-2008
- Secondary IDsMETC, UMC Utrecht: I93-63 
- Public TitleAntibiotics for acute otitis media in children less than 2 years of age.
- Scientific TitlePrimary-care-based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under two years
- ACRONYMTrial with amoxicillin and placebo for AOM
- hypothesisAntibiotics might have more effect in the children less than 2 years of age.
- Healt Condition(s) or Problem(s) studiedChildren, General practitioner, Antibiotics, Acute otitis media
- Inclusion criteria1. Children aged 6 months to two years with acute otitis media in general practice
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-1996
- planned closingdate31-mei-1998
- Target number of participants160
- InterventionsAmoxicillin suspension 40mg/kg/day in three divide doses for 10 days or placebo suspension.
- Primary outcomePersistent 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
- TimepointsEvaluation at 4 days, 11 days, 6 weeks, 3 months and 6 months.
Further first 10 days a diary.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. dr. R.A.M.J. Damoiseaux
- CONTACT for SCIENTIFIC QUERIESProf. dr. R.A.M.J. Damoiseaux
- Sponsor/Initiator Julius Center for Health Sciences and Primary Care
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Organization for Scientific Research (NWO)
- Publications- 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.

- 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.

- 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.

- 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.

- 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.
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD29-aug-2008 - 13-sep-2008


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