AZITHROMYCIN VERSUS PENICILLIN-V IN THE TREATMENT OF PEDIATRIC-PATIENTS WITH ACUTE STREPTOCOCCAL PHARYNGITIS TONSILLITIS

The efficacy and safety of azithromycin and penicillin V in the treatm ent of acute streptococcal pharyngitis/tonsillitis in paediatric patie nts were compared in a double-blind, double-dummy prospective study, A total of 489 children (age range, 2-13 years) were randomized to rece ive treatment with penicillin V (125-250 mg 4 x daily for 10 days) or azithromycin in an oral suspension (10 or 20 mg/kg 1 x daily for 3 day s). Only patients with baseline cultures positive for Streptococcus py ogenes and complete clinical and microbiological assessments at the en d of therapy and follow-up one month later were included in the effica cy analysis. A satisfactory clinical response (cure or improvement) wa s recorded in 99% of the 10 mg/kg azithromycin group, 100% of the 20 m g/kg azithromycin group, and 97% of the penicillin V group at the end of therapy (day 12-14). At the follow-up evaluation (day 28-30), relap se rates in patients cured or improved at the end of therapy were 6%, 5%, and 2%, respectively, Bacteriological eradication rates at the end of therapy were 98% in both azithromycin groups and 92% in patients w ho received penicillin V (p = 0.011); pathogen recurrence was recorded at follow-up in 4% of the 20 mg/kg azithromycin group and in 6% of bo th the 10 mg/kg azithromycin and penicillin V groups. Treatment-relate d adverse events, the majority of mild to moderate severity, occurred in 13% of patients in the 20 mg/kg azithromycin group, 9% in,the 10 mg /kg azithromycin group, and 5% in the penicillin V group. Azithromycin in a dosage of 10 or 20 mg/kg/day once daily for three days was as sa fe and effective as penicillin V administered four times daily in the treatment of paediatric patients with acute pharyngitis/tonsillitis.