Recurrence up to 3.5 years after antibiotic treatment of acute otitis media in very young Dutch children: survey of trial participants.
OBJECTIVE
To determine the long term effects of antibiotic treatment for acute otitis media in young children.


METHODS
Prospective three year follow-up study within the framework of a primary care based, double blind, randomised, placebo controlled trial.


METHODS
53 general practices in the Netherlands.


METHODS
168 children aged 6 months to 2 years with acute otitis media.


METHODS
Amoxicillin 40 mg/kg/day in three doses compared with placebo.


METHODS
Recurrence of acute otitis media; referral to secondary care; ear, nose, and throat surgery.


RESULTS
Acute otitis media recurred in 63% (47/75) of children in the amoxicillin group and in 43% (37/86) of the placebo group (risk difference 20%, 95% confidence interval 5% to 35%); 30% (24/78 amoxicillin; 27/89 placebo) of children in both groups were referred to secondary care, and 21% (16/78) of the amoxicillin group compared with 30% (27/90) of the placebo group had ear, nose, and throat surgery (risk difference -9%, -23% to 4%).


CONCLUSIONS
Recurrent acute otitis media occurred more often in the children originally treated with amoxicillin. This is another argument for judicious use of antibiotics in children with acute otitis media. Trial registration Netherlands Trial Register NTR1426.
Bezáková
Natália
N
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85060, 3508 AB Utrecht, Netherlands.
Damoiseaux
Roger A M J
RA
Hoes
Arno W
AW
Schilder
Anne G M
AG
Rovers
Maroeska M
MM
D000208:Acute Disease; D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D012008:Recurrence
D000900:Anti-Bacterial Agents; D000658:Amoxicillin