Comparative study of 5-day cefcapene-pivoxil and 10-day amoxicillin or cefcapene-pivoxil for treatment of group A streptococcal pharyngitis in children.

In order to compare the bacteriological and clinical efficacy and safety of cefcapene-pivoxil (CFPN-PI) for 5 days, CFPN-PI for 10 days, and amoxicillin (AMPC) for 10 days for the treatment of pharyngitis due to group A beta-hemolytic streptococcus (GAS) in children, a prospective multicenter randomized open-label comparative study was performed with 12 pediatric clinics in Asahikawa between June 2006 and February 2007. Two hundred and fifty children (age range 6 months to 12 years) with signs and symptoms of acute pharyngitis were enrolled. All had a positive throat culture for GAS and were fully evaluable. Eighty-two patients received CFPN-PI 9-10 mg/kg/day three times a day for 5 days, 88 received CFPN-PI three times a day for 10 days, and 80 received AMPC three times a day for 10 days. The CFPN-PI for 5 days regimen, the CFPN-PI for 10 days regimen, and the AMPC for 10 days regimen produced bacteriological eradication at the end of treatment in 93.8%, 96.2%, and 91.7% of the patients, respectively. The clinical cure rate observed at the end of therapy was 100% of the patients in the three groups. Relapse rates were 1.3% in CFPN-PI for 5 days, 4.0% in CFPN-PI for 10 days, and 2.9% in AMPC for 10 days. There were no significant differences in eradication rate, clinical cure rate, and relapse rate between the three treatment groups. The only adverse effects were infrequent diarrhea in all three groups, and a rash which occurred in 6 patients (8.0%) of the AMPC treatment group. Five days of treatment with CFPN-PI was as efficacious in bacteriological eradication and clinical response as 10 days of CFPN-PI or AMPC treatment.

RCT Entities:   Population Interventions Outcomes