EVALUATION OF THE EFFICACY, SAFETY AND TOLERATION OF AZITHROMYCIN VS PENICILLIN-V IN THE TREATMENT OF ACUTE STREPTOCOCCAL PHARYNGITIS IN CHILDREN - RESULTS OF A MULTICENTER, OPEN COMPARATIVE-STUDY

Background, For many years alternatives to penicillin have been studie d for the management of pediatric group A beta-hemolytic Streptococcus (GABHS) pharyngitis, As a result of its pharmacokinetic profile azith romycin is unique among these alternative antimicrobials in allowing o nce daily dosing and shorter duration of treatment, However, the optim um dose (e.g. 10 or 12 mg/kg/day) and duration (e.g. 3 or 5 days) of a zithromycin therapy have not been defined yet, Methods, An open, compa rative multicenter study was conducted in 343 children with clinical s ymptoms of GABHS pharyngitis and a positive culture to evaluate the ef ficacy and safety of azithromycin (10 mg/kg) once daily for 3 days com pared with penicillin V three times daily for 10 days, Results, Among the evaluable patients bacteriologic eradication documented at follow- up visits was inferior with azithromycin when compared with penicillin V therapy: at Days 9 to 20 (mean, 12 days), negative cultures in 65% (99 of 152 patients) vs, 82% (128 of 126 patients) (P < 0.001); and at Days 17 to 57 (mean, 25 days), in 55% vs, 80% (P < 0.001), Overall cl inical success (cure or improvement) was achieved in 93% (149 of 160 p atients) of azithromycin-treated and in 89% (143 of 160 patients) of p enicillin-treated patients (P > 0.50), There was no correlation betwee n bacteriologic response and clinical outcome, as assessed shortly aft er completion of therapy or during 6-month follow-up, Both treatments were well-tolerated, Conclusions, In the present study on GABHS pharyn gitis in children, a once daily (10-mg/kg), 3-day oral regimen of azit hromycin was as clinically effective and as safe as traditional penici llin but appeared inferior in eliminating GABHS from the throat.