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Published on: November 16, 2016
[Clinical evaluation of a new macrolide antibiotic, azithromycin, in the pediatric field]
1Department of Pediatrics, Teikyo University Ichihara Hospital.
Abstract:
Azithromycin (AZM) preparations in fine granules and capsules were evaluated in 36 pediatric patients with various infections. In patients with pneumonia caused by Moraxella catarrhalis, Haemophilus influenzae or Mycoplasma pneumoniae, bronchitis, pharyngitis, scarlet fever, whooping cough, or campylobacter enteritis, AZM was found effective in 94.4% (34/36). As for the bacteriological efficacy of AZM, all of 12 strains identified were found eradicated by the treatment. Plasma T 1/2(24 approximately 48 hrs.) of AZM in fine granules, given two patients at 10 mg/kg body weight once daily for 3 days, were 41.5 and 51.4 hours, while AUC0 approximately infinity was 7.45 and 13.44 mg.hr/ml. The rates of AZM recovered in the urine samples from two pediatrics patients in the first 81 hours of treatment, when it is given in fine granules at 10 mg/kg body weight once daily for 3 days, were 6.27% and 11.0%. Data from 43 patients were included for drug safety evaluation. Neither adverse reactions nor abnormal laboratory changes were observed. In conclusion, AZM was found useful in treatment of pediatric infections.
Insights
Azithromycin (AZM) demonstrated high efficacy in treating pediatric infections, with a 94.4% success rate. This antibiotic was well-tolerated, showing no adverse effects in clinical evaluations.
Area of Science:
- Pediatric infectious diseases
- Pharmacology and pharmacokinetics
- Antimicrobial therapy
Background:
- Pediatric infections pose a significant health challenge, necessitating effective and safe antimicrobial treatments.
- Azithromycin (AZM) is a macrolide antibiotic with broad-spectrum activity, but its efficacy and safety in pediatric populations require specific evaluation.
Purpose of the Study:
- To evaluate the clinical and bacteriological efficacy of Azithromycin (AZM) in pediatric patients with various infections.
- To assess the pharmacokinetic profile and safety of AZM in children.
Main Methods:
- A study involving 36 pediatric patients with diverse infections, including pneumonia, bronchitis, and enteritis.
- Clinical efficacy assessed by treatment outcomes; bacteriological efficacy determined by strain eradication.
- Pharmacokinetic parameters (plasma T 1/2, AUC) and urinary excretion of AZM were measured.
Main Results:
- Azithromycin (AZM) achieved a 94.4% clinical efficacy rate (34/36 patients).
- Bacteriological efficacy was confirmed with 100% eradication of 12 identified bacterial strains.
- Pharmacokinetic data showed plasma half-lives of 41.5 and 51.4 hours; urinary recovery rates were 6.27% and 11.0%.
Conclusions:
- Azithromycin (AZM) is an effective treatment for a range of pediatric infections.
- The drug exhibited a favorable safety profile with no observed adverse reactions or laboratory abnormalities.
- AZM is a valuable therapeutic option for managing infections in pediatric patients.
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