Efficacy, safety, and compliance of cefdinir and cefcapene pivoxil fine granules in children with acute upper respiratory tract infection

Oral cephem antibiotics are commonly used to treat children with acute upper respiratory tract infection. We studied the efficacy, safety, and compliance of a five-day three-dose regimen of cefdinir(CFDN) fine granules at 15 mg/kg daily or cefcapene pivoxil(CFPN-PI) fine granules at 9 mg/kg daily. Because a new improved formulation of CFPN-PI fine granules was introduced by the manufacturer during the study, period we divided the study into period I from January to September 2004, and period II, from October 2004 to April 2006. In period I, CFDN fine granules were administered to 33 patients and CFPN-PI to 36 patients. In period II, each drug was administered to 50 patients. Therapeutic efficacy was calculated based on changes in body temperature and the rate of improvement in clinical symptoms. Efficacy was 100% for period I and 92% for period II in the CFDN group and 100% for period I and 86% for period II in the CFPN-PI group. No significant difference was seen between groups. Soft stool and diarrhea were side effects noted in both groups. For the CFDN group, the incidence of side effects was 12% for period I and 18% for period II. For the CFPN-PI group, the incidence was 14% for period I and 32% for period II, with no significant difference between groups. When we examined compliance, all doses were taken without problem in 81% of the CFDN-treated patients in period I and 83% in period II, and in 57% of the CFPN-PI-treated patients in period I and 67% period II. Although the improved CFPN-PI fine granule formulation demonstrated better compliance than the older formulation, compliance was significantly better in the CFDN group than the CFPN-PI group (p < 0.05). We therefore confirmed the high efficacy and safety of both CFDN fine granule and CFPN-PI fine granule formulations for the treatment of acute upper respiratory tract infections in children. We concluded that CFDN fine granules was a particularly useful therapy because compliance is an important consideration when treating younger children.