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[Bacteriological, pharmacokinetic and clinical studies on clarithromycin in the pediatric field. Pediatric Study
Insights
Clarithromycin demonstrated excellent pediatric efficacy and safety, achieving high clinical success rates against various bacterial infections. This new macrolide antibiotic shows promising results in pediatric treatment regimens.
Area of Science:
- Pharmacology and Microbiology
- Pediatric Infectious Diseases
Background:
- Clarithromycin (TE-031, A-56268) is a novel macrolide antibiotic.
- Pediatric evaluation of its efficacy and safety was conducted by a national study group.
Purpose of the Study:
- To evaluate the bacteriologic and clinical efficacy and safety of clarithromycin in pediatric patients.
- To assess the pharmacokinetic profile and antibacterial activity of clarithromycin.
Main Methods:
- Pharmacokinetic studies involved single oral administration of granules and tablets at various doses.
- Antibacterial effects were tested against key pediatric pathogens.
- Clinical efficacy was assessed in 717 pediatric cases across different disease categories.
Main Results:
- Clarithromycin exhibited favorable pharmacokinetics with predictable blood levels and urinary excretion.
- It demonstrated potent in vitro activity against Streptococcus pneumoniae, Streptococcus pyogenes, Branhamella catarrhalis, and Campylobacter jejuni.
- High clinical efficacy rates were observed: 94.0% in cases with identified pathogens and 90.5% in cases without detected pathogens, with overall rates ranging from 83.9% to 100% across various infections.
Conclusions:
- Clarithromycin is an effective and safe antibiotic for treating a wide range of pediatric infections.
- Its pharmacokinetic and antibacterial properties support its clinical utility in pediatric populations.
Abstract:
Clarithromycin (TE-031, A-56268), a new macrolide antibiotic agent, was evaluated bacteriologically and clinically for its efficacy and safety in pediatrics by a study group organized with pediatricians from all over the country. A summary of the results of the evaluation is as follows. 1. Absorption and excretion Pharmacokinetics of TE-031 was examined by single oral administration of 10% granules and 50 mg tablets at doses of 1, 5, 10 and 15 mg/kg. There were no significant differences between 10% granules and 50 mg tablets, and between administrations before and after meal. Peaks and half-life periods of blood level of TE-031 given once at doses of 5, 10 and 15 mg/kg (10% granules) before meal were 1.58, 4.37 and 3.79 micrograms/ml, and 2.53, 3.17 and 2.20 hours, respectively, and the urinary excretion in 6 hours after the administration were about 20-30%. 2. Antibacterial effects TE-031 was proved to have excellent antibacterial effect, i.e., inhibiting growth over 80% of strains of Streptococcus pneumoniae and Streptococcus pyogenes at 0.10 micrograms/ml, Branhamella catarrhalis at 0.39 micrograms/ml, and Campylobacter jejuni at 0.78 micrograms/ml. Against Staphylococcus aureus, TE-031 showed very similar activity spectrum to EM, and EM resistant strains were also resistant to TE-031. 3. Clinical results A total of 764 cases was studied. Clinical effects of TE-031 were evaluated in 717 cases out of the 764, excluding drop-outs and cases which did not meet specified protocols. Clinically, efficacies of TE-031 were "excellent" in 265 cases and "good" in 161 cases out of 453 cases of Group A in which causal agents were identified, with an efficacy rate of 94.0%, and out of 264 cases of Group B in which pathogens were not detected, clinical effects of TE-031 were "excellent" in 115 cases and "good" in 124 cases, with an efficacy rate of 90.5%. In terms of clinical effects of TE-031 classified by diseases when Group A and B were combined, efficacy rates were 91.6% for upper respiratory tract infection (217/237), 90.0% for bacterial pneumonia (108/120), 97.4% for Mycoplasma pneumonia (111/114), 100% for Chlamydia pneumonia (4/4), 85.0% for pertussis (34/40), 100% for scarlet fever (16/16), 83.9% for skin and soft tissue infection (26/31), and 98.9% for Campylobacter enteritis (87/88).(ABSTRACT TRUNCATED AT 400 WORDS)