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[Clinical study of clarithromycin, a new macrolide antibiotic, in children]
K Hattori1, H Higashino, A Takebe
1Department of Pediatrics, Kansai Medical College.
Insights
Clarithromycin (TE-031) demonstrated good to excellent clinical efficacy in treating pediatric respiratory and skin infections. While safe and effective, improving the taste of the granule formulation is recommended for better palatability in children.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Pharmacology
- Microbiology
Background:
- Clarithromycin (TE-031) is an antibiotic evaluated for pediatric infections.
- The study assessed its efficacy and safety in children with respiratory and skin infections.
Observation:
- Clarithromycin was administered orally to 46 children; 37 were evaluated for efficacy.
- Clinical efficacy was rated good or excellent in 27 out of 37 cases.
- Bacteriological eradication or decrease was observed for Haemophilus influenzae, Haemophilus parainfluenzae, and Staphylococcus aureus.
Findings:
- Clarithromycin showed good to excellent clinical efficacy in 73% of pediatric patients.
- Bacteriological eradication was achieved for targeted pathogens.
- No adverse side effects or abnormal laboratory values were reported.
Implications:
- Clarithromycin (TE-031) is a safe and effective antibiotic for mild to moderate pediatric infections.
- Taste improvement of the granule formulation is needed for enhanced pediatric compliance.
- Further research may focus on optimizing drug delivery for pediatric populations.
Abstract:
1. Clarithromycin (TE-031, A-56268) was given orally to 46 children with respiratory infections, skin infections and others. A total of 9 patients were excluded; 8 patients refused to take the drug because of it's taste, and 1 patient was later found to have viral pneumonia. Clinical efficacy was therefore evaluated in remaining 37 cases and was good or excellent in 27 cases. 2. Bacteriologically, Haemophilus influenzae strains isolated from 4 patients were eradicated in 1 and decreased in 3, respectively. Haemophilus parainfluenzae and Staphylococcus aureus isolated from 1 patient each were both eradicated. 3. Side effect or abnormal laboratory test values were not observed. 4. Based on the above findings, it appears that TE-031 is a safe and is useful antibiotic for the treatment of mild and moderate respiratory infections. It is necessary, however, to improve the taste of the current granule preparation in order to make the drug more easily palatable to children.