P. Marchisio et al., COMPARATIVE-STUDY OF ONCE-WEEKLY AZITHROMYCIN AND ONCE-DAILY AMOXICILLIN TREATMENTS IN PREVENTION OF RECURRENT ACUTE OTITIS-MEDIA IN CHILDREN, Antimicrobial agents and chemotherapy, 40(12), 1996, pp. 2732-2736
Continuous chemoprophylaxis is effective in the prevention of new epis
odes of acute otitis media (AOM) in otitis-prone children, but complia
nce can be a problem and thus efficacy can be decreased. Intermittent
chemoprophylaxis has so far shown conflicting results. Azithromycin, w
hich has a peculiar pharmacokinetics, resulting, even after a single d
ose, in persistently elevated concentrations in respiratory tissues, c
ould permit a periodic administration with higher compliance, We compa
red a 6-month course of once-weekly azithromycin (5 or 10 mg/kg of bod
y weight) with that of once-daily amoxicillin (20 mg/kg) in a single-b
lind, randomized study of prophylaxis for recurrent AOM in 159 childre
n aged 6 months to 5 years with at least three episodes of AOM in the
preceding 6 months, In the amoxicillin group, 23 (31.1%) of 74 childre
n developed 29 episodes of AOM, while in the 10-mg/kg azithromycin gro
up, 11 (14.9%) of 74 children experienced 15 episodes, The 5-mg/kg/wee
k azithromycin trial was prematurely interrupted after nine cases, due
to the high occurrence rate of AOM (55.5%), During the 6-month prophy
laxis period, the proportion of children with middle ear effusion decl
ined similarly in both groups, No substantial modification of the naso
pharyngeal flora was noted at the end of prophylaxis in both antimicro
bial groups, In the 6-month-postprophylaxis follow-up period, about 40
% of children in both groups again developed AOM. Azithromycin at 10 m
g/kg once weekly can be regarded as a valid alternative to once-daily
low-dose amoxicillin for the prophylaxis of AOM. Although in the prese
nt study no microbiological drawback was noted, accurate selection of
children eligible for prophylaxis is mandatory to avoid the risk of em
ergence of resistant strains.