Five-Day Spiramycin vs Seven-Day Penicillin V in the Treatment of Streptococcal Tonsillitis in Children.

Because of the frequency of penicillin allergies in children receiving β-lactam antibacterial agents, the macrolides are frequently chosen as alternatives in patients with group A β-haemolytic streptococcal (GABHS) infections. Spiramycin, amacrolide widely used in paediatrics, achieving remarkably high tonsillar tissue concentrations, was evaluated in this study in comparison with penicillin V (Phenoxymethylpenicillin). 298 children aged 1.5 to 14 years with acute tonsillitis and a positive rapid antigen test for GABHS were randomised to receive either a 5-day course of spiramycin 100 000 IU/kg twice daily or a 7-day course of penicillin V 25 000 IU/kg 3 times daily. Clinical and bacteriological assessments were recorded at inclusion (day 1), at the end of the treatment visit (days 8 to 12), and at the follow-up visit (days 25 to 35). GABHS isolated during the study were analysed by total DNA restriction fragment length polymorphism analysis. Of the 237 children with a positive GABHS culture at day 1,210 (88.6%) were evaluable for complete clinical and bacteriological efficacy at the end of treatment. Clinical efficacy was evident in 96.1% (98 of 102) for spiramycin and in 98.1% (106 of 108) for penicillin V. Bacteriological eradication was achieved in 79.4% (81 of 102) for spiramycin and in 89.8% (97 of 108) for penicillin V. Three failures occurred in the spiramycin group. In intent-to-treat analysis, the success rate (clinical cure and bacteriological eradication) for spiramycin was 77.9% (116 of 149) and 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 without asymptomatic carriage of GABHS was observed in 97.7% (86 of 88) for spiramycin and in 89.4% (89 of 94) for penicillin V. Three relapses and 1 reinfection occurred in the penicillin V group. Adverse events, mainly gastrointestinal, occurred in 10.7% of spiramycin patients versus 12.8% of penicillin V patients. These results show that a 5-day treatment regimen with spiramycin twice daily is effective and well tolerated in GABHS tonsillitis, and is an alternative to penicillin V when necessary in children.

RCT Entities:   Population Interventions Outcomes