Related Experiment Videos
[Laboratory and clinical studies of clarithromycin in pediatric fields]
T Nishimura1, K Tabuki, S Aoki
1Department of Pediatrics, Osaka Medical College.
Insights
Clarithromycin (TE-031) demonstrated high efficacy and safety in pediatric patients. This antibiotic achieved excellent therapeutic responses and pathogen eradication with minimal side effects in children.
Area of Science:
- Pharmacology and Therapeutics
- Pediatric Infectious Diseases
- Microbiology
Context:
- Pediatric bacterial infections pose a significant health challenge.
- Novel antibiotic development is crucial for combating resistant pathogens.
- Understanding drug pharmacokinetics and efficacy in children is essential.
Purpose:
- To evaluate the pharmacokinetics, safety, and efficacy of clarithromycin (TE-031) in pediatric patients.
- To determine serum and urinary concentrations, biological half-lives, and urinary recovery rates.
- To assess therapeutic responses and microbiological effectiveness against common pediatric pathogens.
Summary:
- Clarithromycin (TE-031) was administered orally to children aged 6-11 years at doses of 5-15 mg/kg.
- Peak serum concentrations were observed within 1-2 hours, with biological half-lives ranging from 2.08 to 3.00 hours.
- High therapeutic response rates (89.7%) and a satisfactory eradication rate (82.4%) were achieved with no significant adverse effects.
Impact:
- Clarithromycin (TE-031) is a safe and effective treatment option for various bacterial infections in children.
- The study provides valuable pharmacokinetic and efficacy data for pediatric antibiotic therapy.
- Findings support the use of clarithromycin in managing pediatric respiratory tract infections and other bacterial conditions.
Abstract:
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.