[Clinical studies of cefodizime in the pediatric field].

Cefodizime (CDZM, THR-221) was evaluated for its pharmacokinetics, safety and efficacy in 30 pediatric patients with bacterial infections. The following results were obtained. 1. The pharmacokinetics of CDZM in 6 children were investigated with a dose level of 20 mg/kg via intravenous injection. Mean serum half-lives (T 1/2 beta) of the drug were 120.9 minutes (HPLC) and 115.6 minutes (bioassay). In 8 hours after administration of CDZM, urinary excretion rates were 74.7% (HPLC) and 75.0% (bioassay). 2. The clinical efficacies of CDZM were studied in 29 pediatric patients, comprising 22 with respiratory tract infections, 2 with urinary tract infections, 2 with enteritis, 2 with lymphadenitis and 1 with gingivitis. The clinical efficacies were excellent in 13, good in 13 and fair in 3, with an efficacy rate of 89.7%. 3. The eradication rate for pathogens identified in 7 pediatric patients was 60% (6/10). The clinical efficacy rate in cases where pathogens were identified was 100% in terms of excellent+ good evaluations. 4. Only one case of mild diarrhea was observed as a side effect associated with CDZM. Laboratory tests revealed abnormal value of slightly elevated eosinophil in 3 cases. The data suggested that CDZM is a safe and effective injectable antibiotic for the treatment of infections in children.