[Basic and clinical studies on use of clarithromycin granules in pediatrics]

Studies were conducted on in vivo pharmacokinetics of clarithromycin (TE-031, A-56268) in children and also on the efficacy and the safety of this macrolide antibiotic in the treatment of bacterial infections in children. The results obtained are summarized as follows: 1. TE-031 granules were orally administered to 5 children in a dosage of 5 mg/kg before meal. Maximum drug concentrations (range: 0.29-2.0 micrograms/ml) in the serum occurred during a period from 30 minutes to 1 hour after administration, but there were clear differences in blood concentrations among the individuals. 2. TE-031 granules were orally administered in a average dosage of 20 mg/kg/day to a total of 17 patients, consisting of 14 children with respiratory tract infections and 3 children with intestinal infections. The clinical efficacy evaluation resulted in 10 excellent cases, 6 good cases and 1 fair case, for an efficacy rate of 94.1%. 3. Studies on the bacterial efficacy were carried out for 10 cases. The TE-031 bacteriological efficacy evaluation showed elimination in 7 cases, a decreased bacterial count in 2 cases, and no change in 1 case. The elimination rate was, thus, 70.0%. Elimination rates according to different species of bacteria were 66.7% (2 of 3 strains) for Staphylococcus aureus, 100% for both Streptococcus pneumoniae (3 of 3) and Streptococcus pyogenes (1 of 1), and 42.9% (3 of 7) for Haemophilus influenzae. 4. There were no symptoms which were attributable to side effects of the TE-031 therapy. The only laboratory test abnormality detected was eosinophilia in 1 patient.