Therapy Amoxicillin/Ciavulanic Acid in Paediatric Otitis Media Has comparable efficacy to cefaclor but produces more Gl side effects 131 evaluable children. aged 3 months-12 years. w1th acute otitis med1a were randomly ass1gned to receive amoxicillinjclavulanic ac1d 40/10 mg/kg/day (n = 63) or cefaclor 40 mgjkgjday (68) 1n 3 div1ded daily doses for 10 days in double-blmd fash1on At the completion of therapy. only 2 pat1ents (both 1n the cefaclor treatment group) were cons1dered clin1cal failures (persistence of otalg1a fever or otorrhoea). In one of these patients a Pseudomonas sp had been isolated from the m1ddle ear at entry The percentage of effus1on-free ears was similar in both groups after treatment. being 75 3% for amoxiCillmjclavulanic ac1d and 64.4% for cefaclor During the 90day follow-up period both groups showed a decrease 1n the frequency of middle ear disease with no significant difference between the groups The recurrence rates were similar for those pat1ents w1th (47%) or without (56%) middle ear effusion at day 10. Similarly, there was no difference in recurrence rate between the treatment groups. However, recurrence was signJf1cantly more frequent in children aged < 2 years (55%) than in those aged 2-5 years (23%) or > 6 years (11 %). Of the 17 patients with 13-lactamase-producing middle ear isolates, all were clinical 'successes· at day 10 and equal proportions in both treatment groups were free of effusion at 5, 10, 30, 60 and 90 days The incidence of side effects (predominantly gastrointestinal) was significantly higher in the amoxicillinjclavulanic acid recipients (33% of patients) than in the cefaclor recipients (13%). The distribution of adverse effects in the respective groups was diarrhoea (12 vs 7), vomit1ng (6 vs 0), loose bowels, pain and nausea (0 vs 1), rash (5 vs 5), neutropenia (6 vs 1) and eosinophilia (0 vs 1). Thus, amoxicillinjclavulanic acid was comparable in efficacy to cefaclor in the treatment of acute otitis media in children, but was associated with a higher incidence of mild gastrointestinal s1de effects. Kaleida PH. Bluestone CD. Rockette HE. Bass LW. Wolfson JH. et al Pedoatnc lnfectoous D1sease 6 265-271 March 1987

0156-2703/87/0620-0007/0$01.00/0 © AOIS Press

INPHARMA • 20 June 1987

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