[Bacteriological, pharmacokinetic and clinical studies on cefteram pivoxil in the pediatric field].

Bacteriological, pharmacokinetic and clinical studies were done on the effect of cefteram pivoxil (CFTM-PI, T-2588) (10% granules), a new oral cephalosporin, in the field of pediatrics. The results are summarized below. 1. Antibacterial activities Antibacterial activities of CFTM against Staphylococcus aureus and Streptococcus pyogenes were studied comparatively with activities of cefaclor (CCL), cephalexin (CEX) and ampicillin (ABPC). MICs of CFTM against S. aureus were distributed in a range between 0.78 and 12.5 micrograms/ml, with a peak value of 3.13 micrograms/ml, which were similar to MIC ranges of CEX and CCL. MICs of CFTM against all strains of S. pyogenes were less than or equal to 0.025 microgram/ml, which were similar to MIC of ABPC. CFTM was approximately 2 to 3 folds more effective than CCL or CEX. 2. Absorption and excretion. Serum concentrations and urinary excretions of CFTM were determined in doses of 3 mg/kg (non-fasting) and 6 mg/kg (non-fasting and fasting). In non-fasting subjects, peak concentrations of CFTM in serum were dose-dependent and were 1.15-2.3 micrograms/ml and 1.8-3.6 micrograms/ml at 2-3 hours, 0.125-0.78 micrograms/ml and 0.245-0.97 micrograms/ml at 6 hours, respectively, for the 2 dose levels. Serum half-lives were 1.03-2.65 hours for the dose of 3 mg/kg and 1.07-1.83 hours for 6 mg/kg. In fasting subjects, the mean peak serum concentrations were 1.73 micrograms/ml at 2 hours and 1.13 micrograms/ml at 6 hours for the dose of 6 mg/kg. Urinary recovery rates in the first 6 hours varied 5.3-19.2%. 3. Clinical study Clinical efficacies were examined in a total of 41 cases including 9 cases of bacterial pneumonia, 10 cases of bronchitis, 11 cases of tonsillitis, 7 cases of urinary tract infections, 3 cases of scarlet fever and 1 case of otitis media. Clinical efficacies were excellent in 30 cases, good in 10 cases, poor in 1 case, hence the efficacy rate was 97.6%. All of the 28 bacteria identified in these cases were eradicated after CFTM-PI treatments. No noticeable abnormalities were found as side effects. An elevation of eosinophil, an increase of platelet count and elevations of GOT and GPT were observed in 3 patients.