5-DAY-SPIRAMYCIN VS 7-DAY-PENICILLIN-V IN THE TREATMENT OF STREPTOCOCCAL TONSILLITIS IN CHILDREN

Because of the frequency of penicillin allergies in children receiving beta-lactam antibacterial agents, the macrolides are frequently chose n as alternatives in patients with group A beta-haemolytic streptococc al (GABHS) infections. Spiramycin, a macrolide widely used in paediatr ics, achieving remarkably high tonsillar tissue concentrations, was ev aluated in this study in comparison with penicillin V (phenoxymethylpe nicillin). 298 children aged 1.5 to 14 years with acute tonsillitis an d a positive rapid antigen test for GABHS were randomised to receive e ither a 5-day course of spiramycin 100 000 IU/kg twice daily or a 7-da y course of penicillin V 25 000 IU/kg 3 times daily. Clinical and bact eriological assessments were recorded at inclusion (day 1), at the end of the treatment visit (days 8 to 12), and at the follow-up visit (da ys 25 to 35). GABHS isolated during the study were analysed by total D NA restriction fragment length polymorphism analysis. Of the 237 child ren with a positive GABHS culture at day 1, 210 (88.6%) were evaluable for complete clinical and bacteriological efficacy at the end of trea tment. Clinical efficacy was evident in 96.1% (98 of 102) for spiramyc in and in 98.1% (106 of 108) for penicillin V. Bacteriological eradica tion was achieved in 79.4% (81 of 102) fur spiramycin and in 89.8% (97 of 108) for penicillin V. Three failures occurred in the spiramycin g roup. In intent-to-treat analysis, the success rate (clinical cure and bacteriological eradication) for spiramycin was 77.9% (116 of 149) an d that for penicillin V was 83.9% (125 of 149). At the follow-up visit , 182 children were evaluable for efficacy. Clinical cure with or with out asymptomatic carriage of GABHS was observed in 97.7% (86 of 88) fo r spiramycin and in 89.4% !(89 of 94) for penicillin V. Three relapses and I reinfection occurred in the penicillin V group. Adverse events, mainly gastrointestinal, occurred in 10.7% of spiramycin patients ver sus 12.8% of penicillin V patients. These results show that a 5-day tr eatment regimen with spiramycin twice daily is effective and well tole rated in GABHS tonsillitis, and is an alternative to penicillin V when necessary in children.