Efficacy and safety of roxithromycin in treating paediatric patients. A European multicentre study.

Roxithromycin sachets of 50 mg were given to 304 infants and children, aged 2 months to 14 years, suffering from respiratory and skin infections treated in 25 hospitals in France and one in Greece. The dosage range was from 2.5 to 5.0 mg/kg/12 h and the mean duration of therapy was 8.9 days. The cure rate was 89% of the 266 children evaluable for clinical efficacy and 90.3% of the 50 bacteriologically identified cases. The overall bacteriological efficacy was 82%. The antibiotic was well accepted by the 90% of the 304 children, while in 6.9% an adverse effect was reported, mainly vomiting. There were no toxic effects. Roxithromycin should be considered as an effective and safe oral antibiotic to treat children with upper and lower respiratory tract and skin infections due to common pathogens.