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[Basic and clinical studies on use of clarithromycin granules in pediatrics]
Insights
This study evaluated clarithromycin (TE-031) in children, finding it effective and safe for bacterial infections. Pharmacokinetic analysis showed variable serum concentrations, but clinical trials demonstrated a 94.1% efficacy rate with minimal side effects.
Area of Science:
- Pharmacology
- Pediatrics
- Infectious Diseases
Context:
- Bacterial infections pose a significant health risk in children.
- Macrolide antibiotics are crucial for treating various pediatric infections.
- Understanding the pharmacokinetics and clinical efficacy of new antibiotics is vital for pediatric care.
Purpose:
- To assess the in vivo pharmacokinetics of clarithromycin (TE-031) in children.
- To evaluate the clinical efficacy and safety of clarithromycin (TE-031) for treating bacterial infections in pediatric patients.
- To determine the bacteriological efficacy of clarithromycin (TE-031) against specific bacterial strains.
Summary:
- Oral administration of TE-031 granules in children showed maximum serum concentrations within 0.5 to 1 hour, with notable inter-individual variability.
- Clinical evaluation of 17 pediatric patients with respiratory and intestinal infections revealed an overall efficacy rate of 94.1% (10 excellent, 6 good, 1 fair).
- Bacteriological studies demonstrated a 70% elimination rate, with high efficacy against Streptococcus pneumoniae and Streptococcus pyogenes, moderate against Staphylococcus aureus, and lower against Haemophilus influenzae. No significant adverse effects were reported, except for transient eosinophilia in one patient.
Impact:
- Provides crucial pharmacokinetic and efficacy data for clarithromycin (TE-031) in pediatric populations.
- Supports the use of clarithromycin as a safe and effective treatment option for common pediatric bacterial infections.
- Contributes to evidence-based guidelines for antibiotic selection in pediatric infectious disease management.
Abstract:
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.