[A clinical study on cefteram pivoxil in the field of pediatrics]

Cefteram pivoxil (CFTM-PI, T-2588), a new oral cephem antibiotic of ester type, was evaluated for its safety, efficacy and pharmacokinetics. 1. One child, 4 years of age (18 kg body weight), was administered orally 3 mg/kg after meal. The peak serum level of CFTM was 0.78 microgram/ml after 2 hours, and cumulative urinary excretion rate during the first 6 hours was 15.0%. 2. Clinical studies on CFTM-PI were carried out in 17 pediatric patients; 1 with acute pharyngitis, 2 with acute tonsillitis, 1 each with pertussis, acute bronchitis, 2 with broncho-pneumonia, 4 with scarlatina, 3 with acute otitis media, and 1 each with lymphadenitis, acrobystitis and urinary tract infection. Clinical responses were excellent in 9, good in 6, fair in 1, poor in 1, and the overall clinical efficacy rate was 88.2%. 3. Bacteriological efficacy was investigated with 10 strains of 5 species (Streptococcus pyogenes 4, Streptococcus pneumoniae 2, Haemophilus influenzae 2, Enterococcus and Bacteroides 1) isolated from 9 patients. All strains were eradicated. 4. As to adverse reactions, mild diarrhea was observed in 1 patient. But therapy had to be continued without procedure and the diarrhea disappeared after 6 days. No adverse hematological, renal or hepatic effects were noted.