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[Basic and clinical studies on cefditoren pivoxil in pediatric field]
T Motohiro1, S Handa, S Yamada
1Department of Pediatrics, School of Medicine, Kurume University.
The Japanese Journal of Antibiotics
|April 1, 1994
Summary
Cefditoren pivoxil (CDTR-PI) demonstrates potent antibacterial activity against common pathogens and shows excellent clinical efficacy and safety in pediatric infectious disease patients. This new oral cephem offers a promising treatment option with minimal side effects.
Area of Science:
- Pharmacology
- Infectious Diseases
- Pediatrics
Background:
- Cefditoren pivoxil (CDTR-PI) is a novel oral cephem antibiotic.
- Pediatric infectious diseases require effective and safe treatment options.
Purpose of the Study:
- To evaluate the antibacterial activity, pharmacokinetics, clinical efficacy, and safety of CDTR-PI in pediatric patients.
- To assess CDTR-PI's effectiveness against clinical isolates from pediatric patients.
Main Methods:
- In vitro sensitivity testing against 30 clinical isolates (5 species).
- Oral administration of CDTR-PI (3.0 mg/kg and 6.0 mg/kg) to pediatric patients to determine plasma and urinary concentrations.
- Clinical evaluation of efficacy and safety in 53 pediatric patients with various infectious diseases.
Main Results:
- CDTR-PI exhibited potent activity against Gram-positive and Gram-negative bacteria, with MICs comparable or superior to conventional agents.
- Pharmacokinetic studies showed dose-dependent peak plasma concentrations and AUCs, with significant urinary recovery.
- Clinical efficacy was excellent in 60.4% and good in 39.6% of patients, with a 96.7% bacterial eradication rate and no observed side effects.
Conclusions:
- Cefditoren pivoxil demonstrates strong in vitro antibacterial activity and favorable pharmacokinetic properties.
- CDTR-PI is clinically effective and well-tolerated in pediatric patients with infectious diseases, showing high efficacy and a favorable safety profile.