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Indexed/Abstracted in: CAB, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 0,532
Online ISSN 1827-1715
Bottaro G. 1, Biasci P. 2, Lo Giudice M. 3, Mele G. 4, Montanari G. 5, Napoleone E. 6, Santucci A. 7, Tucci P. L. 8, Fano M. 8, Biraghi M. G. 9
1 Pediatra di Famiglia, Catania, Italia;
2 Pediatra di Famiglia, Livorno, Italia;
3 Pediatra di Famiglia, Palermo, Italia;
4 Presidente FIMP; Pediatra di Famiglia, Lecce, Italia;
5 Pediatra di Famiglia, Pordenone, Italia;
6 Pediatra di Famiglia, Campobasso, Italia;
7 Pediatra di Famiglia, Perugia, Italia;
8 Pediatra di Famiglia, Firenze, Italia;
9 Direzione Medica Valeas
AIM: The duration of therapy represents a fundamental aspect in the compliance to the therapy of child pathologies, such as pharyngotonsillitis, treated with oral therapy. Although penicillin and amoxicillin are the first choice antibiotics in the case of a child suffering from pharyngotonsillitis with the proven presence of Group A β-hemolytic Streptococcus (GAS), the number of orally administered doses and 10 days of therapy, considerably lower the compliance.
METHODS: An open phase IV randomized multicenter clinical trial was conducted in parallel groups, involving 49 family pediatrician (FP), distributed over the entire national territory, enrolling 435 children suffering from GAS-FT. 210 children received Cefaclor, 50 mg/kg/day, administered twice daily for five days, whilst 213 children received amoxicillin/clavulanate 40 mg/kg/day administered twice daily for 10 days.
RESULTS: The results showed percentages of eradication of 88.4% for the Cefaclor group and 94.3% for the amoxicillin/clavulanate group, and a positive clinical judgement of 92.3% for the Cefaclor group and 96.6% for the amoxicillin/clavulanate group. The two arms of the study did not have any significant statistical differences, neither for the eradication, nor for the clinical judgement nor for the reduction of the Milano Score between the beginning and the end of treatment, with a P=0.042 for amoxicillin/clavulanate for eradication.
CONCLUSION: This study confirms that the administration of Cefaclor for five days during GAS-FT has the same efficacy as a 10-day therapy with amoxicillin/clavulanate, with a clearly different compliance.