A comparative study of the efficacy, safety and tolerance of azithromycin, dicloxacillin and flucloxacillin in the treatment of children with acute skin and skin-structure infections.

An open, randomized, multicentre study was undertaken to compare a three-day regimen of azithromycin with a seven-day course of dicloxacillin or flucloxacillin in the treatment of 118 children (aged 2-12 years) with clinically diagnosed acute skin and skin-structure infections. Sixty patients received a single daily dose of azithromycin of 10 mg/kg for three days, whilst 58 received a cloxacillin ester: either dicloxacillin (n = 49) at a daily dose of 12.5-25 mg/kg (depending on severity of infection); or flucloxacillin (n = 9) at 250-2000 mg/day (depending on age). Both cloxacillin esters were administered in four divided doses for seven days. Clinical, safety and, where possible, bacteriological assessments were made before therapy and after 3 to 5 and 7 to 10 days of treatment. A successful clinical response (cure and improvement) was recorded in 57 of 59 (97%) of evaluable azithromycin patients, and in 57 of 58 (98%) of cloxacillin ester patients. Eradication of the key pathogens was 31 of 34 (91%) and 34 of 35 (97%) for Staphylococcus aureus, and 5 of 5 and 4 of 4 for Streptococcus pyogenes in the azithromycin and cloxacillin ester groups, respectively. Both medications were well tolerated, with mild to moderate side-effects (abdominal pain and vomiting) occurring in two patients in each group, and laboratory abnormalities (elevated eosinophil count) in one patient in each group. There were no withdrawals from therapy. The results of this study suggest that azithromycin is as effective and as well tolerated as a cloxacillin ester antibiotic in the treatment of children with acute skin and skin-structure infections.

RCT Entities:   Population Interventions Outcomes