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[Clinical study of a macrolide antibiotic, azithromycin, in pediatric patients]
Y Kobayashi1, M Kino, H Higashino
1Department of Pediatrics, Kansai Medical University.
Insights
Azithromycin (AZM) demonstrated significant clinical efficacy and a favorable safety profile in pediatric infections. This oral antibiotic showed high effectiveness, making it a valuable treatment option for children with susceptible bacterial infections.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Clinical Microbiology
Background:
- Pediatric infections require effective and safe antimicrobial agents.
- Azithromycin is a macrolide antibiotic with broad-spectrum activity.
- Understanding the pharmacokinetic and clinical profile of oral Azithromycin in children is crucial.
Purpose of the Study:
- To evaluate the pharmacokinetic properties of oral Azithromycin in pediatric patients.
- To assess the clinical efficacy and safety of Azithromycin in treating various pediatric infections.
- To determine the bacteriological response to Azithromycin treatment.
Main Methods:
- Oral administration of Azithromycin (10% fine granules or 100 mg capsules) to 27 pediatric patients.
- Pharmacokinetic analysis involving plasma and urinary Azithromycin concentrations.
- Clinical efficacy assessment in 24 patients and safety evaluation in 26 patients.
Main Results:
- High clinical efficacy rate of 87.5% (7 excellent, 14 good responses).
- Successful eradication or reduction of Haemophilus influenzae in isolates.
- Favorable safety profile with only one case of urticaria reported; minor laboratory abnormalities in two patients.
Conclusions:
- Oral Azithromycin is an effective and well-tolerated antibiotic for pediatric infections.
- The pharmacokinetic data support its use in children.
- Azithromycin represents a valuable therapeutic option for pediatric patients with infections caused by susceptible organisms.
Abstract:
Azithromycin (AZM), 10% fine granules or 100 mg capsules, were given orally to 27 children with various pediatric infections. The results of the study are shown below. 1. Pharmacokinetic investigation. We studied plasma and urinary concentrations after 100 mg AZM capsules were given. One patient received 8.3 mg/kg of AZM once a day for 3 days, and AZM concentration in plasma was 0.033 microgram/ml 48 hours after the final dosing. Doses of 8.3 and 12.5 mg/kg body weight of AZM were respectively given to two patients once daily for 3 days. As a result, AZM concentrations in urine during a period between 96 and 120 hours post-dosing were 1.67 and 4.53 micrograms/ml, respectively, and urinary excretion rate in 120 hours after the first dosing was 10.54% in the patient that was given 12.5 mg/kg. 2. Clinical investigation. Clinical efficacies were examined in 24 patients. Excellent results were obtained in 7 patients, good results in 14 patients, hence the clinical efficacy rate was 87.5%. Bacteriologically, Haemophilus influenzae strains isolates from 2 patients were eradicated in 1 and decreased in the other. Safety was evaluated in 26 patients. An adverse reaction was observed in 1 patient (urticaria). Abnormal laboratory test results were observed in 2 patients, decreased WBC in 1 and elevation of eosinophils in the other. The above results suggest that AZM is a useful oral antibiotic for pediatric patients with infection with susceptible organisms.