[Clinical evaluation of clarithromycin in pediatric patients]
Insights
Newly synthesized macrolide antibiotic TE-031 (clarithromycin) demonstrated 100% efficacy and excellent safety in pediatric patients. Pharmacokinetic studies showed higher blood concentrations and urinary recovery rates compared to other macrolides.
Area of Science:
- Pharmacology
- Microbiology
- Pediatrics
Context:
- Macrolide antibiotics are crucial for treating bacterial and mycoplasmal infections.
- New antibiotic development is essential to combat evolving pathogens and resistance.
- Pediatric populations require specific safety and efficacy evaluations for medications.
Purpose:
- To evaluate the clinical efficacy and safety of clarithromycin (TE-031) in pediatric patients.
- To assess the pharmacokinetic profile of TE-031 following oral administration.
- To determine the in vitro antimicrobial activity of TE-031 against relevant pathogens.
Summary:
- Clarithromycin (TE-031) was administered to 30 pediatric patients (8 months to 12 years) with mycoplasmal and bacterial infections.
- Pharmacokinetic analysis revealed higher blood concentrations and urinary recovery rates for TE-031 compared to other macrolides.
- Clinical evaluations showed a 100% efficacy rate (19 excellent, 11 good) with no adverse reactions or laboratory abnormalities.
- In vitro studies demonstrated potent activity against Streptococcus pneumoniae, Haemophilus influenzae, and Branhamella catarrhalis.
Impact:
- TE-031 shows promise as a safe and effective antibiotic for treating pediatric infections.
- The favorable pharmacokinetic profile suggests potential for improved therapeutic outcomes.
- This study supports the development of TE-031 as a valuable new antimicrobial agent for children.
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.
