Material and methods. - In this randomized open study, 325 children aged tw
o to 15 years with acute tonsillitis and a positive test of GA betaH strept
ococcal antigen were treated with josamycin 50 mg(.)kg(-1)-day(-1) b.i.d fo
r 5 days, or penicillin 50,000 to 100,000 IU/day t.i.d for 10 days. Clinica
l assessments and throat cultures for GA beta HS isolation were performed a
t the inclusion visit (VI), at the end of treatment visit (V2: day 12 for a
ll patients) and at the follow-up visit (V3: day 30). In case of positive G
A beta HS culture, the bacterial DNA by RFLP was performed to differentiate
between the persistence (presence of original strain at V2), relapse (erad
ication at V2 and acquisition of same strain at VS) and reinfection (eradic
ation at V2 and acquisition of different strain at V3).
Results. - Two hundred and twenty-three patients were included in the bacte
riological and clinical criteria per protocol analysis. At V2, eradication
rates were comparable: 82% in josamycin and 80% in penicillin patients; cli
nical cure rates were 90% and 89%. At V3, relapse of GAS assessed only on c
linically and bacteriologically cured patients at V2 occurred in 12% of jos
amycin patients and 12.8% of penicillin patients. Tolerance was good; 14% a
nd 10% of josamycin and penicillin patients respectively experienced an adv
erse event.
Conclusion. - In this non-inferiority study, the efficacy of a 5-day course
of josamycin is comparable to reference treatment in GA beta HS tonsilliti
s in children. (C) 2001 Editions scientitiques et medicales Elsevier SAS.