Tolerability of 3-day, once-daily azithromycin suspension versus standard treatments for community-acquired paediatric infectious diseases

Tolerability of azithromycin oral suspension, 10 mg/kg once daily for 3 day s, was assessed in paediatric patients (less than or equal to 18 years) wit h respiratory or skin and soft-tissue infections. Of 2425 patients evaluate d, 1213 received azithromycin and 1212 received standard regimens of amoxyc illin; clavulanic acid, cefaclor, cefixime, ceftriaxone, clarithromycin, er ythromycin, or penicillin V. The incidence of treatment-related adverse eve nts was significantly lower in patients receiving azithromycin than compara tors (7.9 vs. 11.5%, P = 0.003), while discontinuation rates were similar ( 1.0 and 1.1%, respectively). Significantly fewer gastrointestinal events we re recorded for azithromycin than comparators (6.5 vs. 9.9%, P = 0.002), an d their duration was significantly shorter (mean 2.3 vs. 5.0 days, P = 0.00 01). Azithromycin paediatric oral suspension is well tolerated and associat ed with significantly fewer adverse events than comparators. (C) 2001 Elsev ier Science B.V. and International Society of Chemotherapy. All rights rese rved.