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[Laboratory and clinical studies of clarithromycin in pediatric fields].

We have carried out laboratory and clinical studies on clarithromycin (TE-031, A-56268). The results are summarized as follows. Serum and urinary concentrations of TE-031 were determined in 5 children with ages between 6 and 11 years given single oral doses of 5, 6.7, 10 and 15 mg/kg. Serum concentrations peaked at 1 hour after administration of 5, 6.7 and 15 mg/kg, and respective peak values were 1.98 micrograms/ml, 2.21 micrograms/ml and 5.58 micrograms/ml. Biological half-lives for the drug at 5, 6.7 and 15 mg/kg dose were 2.99 hours, 2.08 hours and 2.09 hours, respectively. Mean serum concentrations peaked at 2 hours after administration of 10 mg/kg, and peak values were 3.91 +/- 1.64 micrograms/ml. Biological half-lives were 3.00 +/- 0.58 hours. The 6-hour urinary recovery rates ranged from 22.7% to 23.8% after administration of 10 mg/kg, and the 6-hour urinary recoveries were 30.1%, 20.5% and 39.1% after administration of 5 mg/kg, 6.7 mg/kg and 15 mg/kg, respectively. Therapeutic responses were recorded as excellent or good in 35(89.7%) of the children, comprising 5 with tonsillitis, 3 with pharyngitis, 7 with bronchitis, 5 with pneumonia, 15 with Mycoplasma pneumonia, 1 with whooping cough and 3 with Campylobacter enteritis. The microbiological effectiveness of TE-031 on identified pathogens comprising 2 strains of Streptococcus pneumoniae, 5 strains of Haemophilus influenzae, 2 strains of Haemophilus parainfluenzae, 5 strains of Mycoplasma pneumoniae and Campylobacter spp. was satisfactory as evidenced by an eradication rate of 82.4%. No significant side effect due to the drug was observed in any cases. In conclusion, TE-031 was found to be efficacious and safe for the treatment of bacterial infections in children.