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[Laboratory and clinical studies on clarithromycin in the field of pediatrics]
1Department of Pediatrics, Anjo Kosei Hospital.
Insights
New pediatric antibiotic clarithromycin (TE-031) shows promising results. It demonstrates effective serum concentrations, potent antibacterial activity against common pathogens, and high clinical efficacy in treating pediatric infections with no observed side effects.
Area of Science:
- Pediatric infectious diseases
- Pharmacokinetics and pharmacodynamics of antibiotics
- Macrolide antibiotic research
Context:
- Clarithromycin (TE-031) is a novel macrolide antibiotic investigated for pediatric applications.
- Understanding its pharmacokinetic profile and in vitro activity is crucial for clinical use.
Purpose:
- To evaluate the pharmacokinetics, antibacterial spectrum, clinical efficacy, and safety of clarithromycin (TE-031) in pediatric patients.
- To compare its efficacy against other antibiotics like josamycin, erythromycin, and ampicillin.
Summary:
- Oral administration of clarithromycin (TE-031) in pediatric patients resulted in measurable serum concentrations with half-lives of 2.2-7.5 hours and urinary recovery rates of 7.1-34.5%.
- In vitro studies demonstrated that TE-031 possesses antibacterial activity superior to josamycin and comparable to erythromycin against key pediatric pathogens, including Streptococcus pneumoniae and Haemophilus influenzae.
- Clinical trials involving 55 pediatric patients with acute infectious diseases showed high efficacy rates of 96% clinically and 72% bacteriologically, with no reported side effects or adverse laboratory findings.
Impact:
- Clarithromycin (TE-031) presents a safe and effective therapeutic option for treating various acute infectious diseases in children.
- The findings support the potential of clarithromycin as a valuable addition to the pediatric antibiotic armamentarium.
Abstract:
Laboratory and clinical studies on clarithromycin (TE-031, A-56268), a new macrolide antibiotic, were carried out in the field of pediatrics. The results obtained are summarized as follows: 1. Serum concentrations, urinary concentrations and urinary recovery rates were determined upon oral administration on fasting of TE-031 at doses of 5 mg/kg granules in 1 case and tablets in 2 cases, and 10 mg/kg granules in 1 and 15 mg/kg granules in 1. Peak serum levels were obtained at 30 minutes in 2 cases, at 1 hour in 2 cases and at 2 hours in 1 case after administration of the drug with a range of 2.29-7.10 micrograms/ml with half-lives of 2.2-7.5 hours. Urinary recovery rates in 6 hours after administration ranged from 7.1-34.5%. 2. MICs of TE-031 against 49 clinical isolates (Streptococcus pyogenes 5 strains, Streptococcus pneumoniae 9, Staphylococcus aureus 3, Branhamella catarrhalis 4, Haemophilus influenzae 14, Haemophilus parainfluenzae 7, and Campylobacter jejuni 7) were compared with those of josamycin (JM), erythromycin (EM), and ampicillin (ABPC). The antibacterial activity of TE-031 was superior to those of JM and equal to those of EM. 3. Fifty-five pediatric patients with acute infectious diseases (scarlet fever 3 cases, pharyngitis and tonsillitis 15, pertussis 2, pneumonia 10, bronchitis 14, Campylobacter enteritis 11) were treated with TE-031 at daily doses of 10-35 mg/kg t.i.d. as a rule. The efficacy rates were 96% clinically and 72% bacteriologically. 4. Side effects or abnormal laboratory test values were not observed. 5. None of children refused TE-031.