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  • Title: [Clinical evaluation of clarithromycin in pediatric patients].
    Author: Ito S, Mayumi M, Mikawa H.
    Journal: Jpn J Antibiot; 1989 Feb; 42(2):343-51. PubMed ID: 2526247.
    Abstract:
    A clinical evaluation of clarithromycin (TE-031, A-56268), a newly synthesized macrolide antibiotic, was made for its efficacy and safety in 30 patients with ages ranging from 8 month-old to 12 year- 2 month-old with mycoplasmal and bacterial infections. The obtained results are summarized below. 1. A pharmacokinetic study following oral administration of TE-031 at 10 mg/kg (granule) or 5.5 mg/kg (tablet) resulted in blood concentrations and urinary recovery rates higher than with other macrolides. 2. TE-031 was administered orally to 5 patients with Mycoplasma pneumonia, 21 patients with pneumonia or bronchopneumonia, 2 patients with pertussis and 2 patients with enterocolitis at daily dosages ranging 11.1-31.6 mg/kg divided into 3. Clinical evaluations of these 30 patients were as follows; excellent: 19 patients, good: 11 patients. The efficacy rate was 100%. 3. Neither clinical adverse reaction nor abnormal laboratory data was found in any of these 30 patients. 4. MICs of TE-031 against 10 strains of bacteria isolated from 10 patients with pneumonia or bronchopneumonia were as follows. MICs against 3, 2 and 2 out of 7 strains of Streptococcus pneumoniae were less than 0.025 microgram/ml, 0.05 microgram/ml and 0.10 microgram/ml, respectively. MIC against a strain of Haemophilus influenzae was 3.13 micrograms/ml. MICs of 2 strains of Branhamella catarrhalis were 0.20 microgram/ml. 5. TE-031 is considered to be a new useful and safe antibiotic in pediatric patient with an excellent bactericidal capacity.
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