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British Journal of Clinical Pharmacology
Volume 54 Issue 6 Page 652 - December 2002
Methods This was a multicentre, equivalence, randomized, double-blind trial of two parallel groups comparing 5 days of amoxicillin/clavulanic acid 75 mg kg
1 day1
(i.e. 25 mg kg1
every 8 h) and placebo. The main outcome measure was acute otitis media
occurring within 8-12 days of initiating treatment.
Results Two hundred and three
infants, aged 3 months3 years
with upper respiratory tract infection over 36 h and a history of recurrent
acute otitis media were included over 8.5 months. Two children were lost to
follow-up. Patient characteristics were similar in both groups. In the
intention to treat analysis the frequency of acute otitis media was 16.2%
(16/99) in the placebo group and 9.6% (10/104) in the amoxicillin/clavulanic
acid group (P = 0.288). The difference between acute otitis media
rates was 6.6% (one-sided 95% confidence interval of 14.3%). The occurrence
of side-effects was similar in the amoxicillin/clavulanic acid and placebo
groups.
Conclusions The difference in
effectiveness between antibiotic and placebo was not greater than 14.3%, and
we calculated that 94 children would need to be exposed to antibiotics to
avoid six cases of acute otitis media. In view of the risk of development of
resistance due to frequent exposure to antibiotics, our study supports the
need for reduction in the administration of antibiotics in upper respiratory
tract infection even in children at high risk of acute otitis media.
