|- candidate number||3888|
|- NTR Number||NTR1426|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-aug-2008|
|- Secondary IDs||METC, UMC Utrecht: I93-63 |
|- Public Title||Antibiotics for acute otitis media in children less than 2 years of age.|
|- Scientific Title||Primary-care-based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under two years|
|- ACRONYM||Trial with amoxicillin and placebo for AOM|
|- hypothesis||Antibiotics might have more effect in the children less than 2 years of age. |
|- Healt Condition(s) or Problem(s) studied||Children, General practitioner, Antibiotics, Acute otitis media|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-1996|
|- planned closingdate||31-mei-1998|
|- Target number of participants||160|
|- Interventions||Amoxicillin suspension 40mg/kg/day in three divide doses for 10 days or placebo suspension.|
|- 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
|- Timepoints||Evaluation at 4 days, 11 days, 6 weeks, 3 months and 6 months.|
Further first 10 days a diary.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. R.A.M.J. Damoiseaux|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. R.A.M.J. Damoiseaux|
|- Sponsor/Initiator ||Julius Center for Health Sciences and Primary Care|
(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 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.|
|- Main changes (audit trail)|
|- RECORD||29-aug-2008 - 13-sep-2008|