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[Pharmacokinetic, bacteriological and clinical evaluation of cefditoren pivoxil in pediatrics]
1Department of Pediatrics, Meitetsu Hospital.
Insights
Cefditoren pivoxil (CDTR-PI) demonstrates favorable pharmacokinetics and a 100% clinical efficacy rate in pediatric patients with various infections. This antibiotic showed a high eradication rate against common pediatric pathogens with no observed adverse reactions.
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Antibiotic Therapy
Background:
- Cefditoren pivoxil (CDTR-PI) is an oral third-generation cephalosporin antibiotic.
- Pediatric studies are essential to establish appropriate dosing and efficacy for this population.
Observation:
- Pharmacokinetic analysis in children aged 1-10 years showed dose-dependent serum concentrations and urinary excretion of CDTR.
- Clinical evaluation in 31 pediatric patients with infections demonstrated a 100% efficacy rate.
- Bacteriological assessment revealed an 87.5% eradication rate against common pediatric pathogens.
Findings:
- CDTR-PI exhibited favorable pharmacokinetic profiles in children, with peak serum concentrations achieved within 1-2 hours post-administration.
- The drug was highly effective in treating pediatric infections such as scarlet fever, tonsillitis, and pneumonia.
- High eradication rates were observed against Staphylococcus aureus, Streptococcus pyogenes, and beta-Streptococcus, with no adverse side effects reported.
Implications:
- Cefditoren pivoxil is a safe and effective antibiotic option for treating bacterial infections in pediatric patients.
- Further research may explore its use in different pediatric age groups and for a broader range of infections.
- The observed pharmacokinetic and efficacy data support the use of CDTR-PI in pediatric clinical practice.
Abstract:
Pharmacokinetic, bacteriological, and clinical studies were performed in pediatrics on cefditoren pivoxil (CDTR-PI, ME1207) in granules. 1. Serum concentrations and urinary excretions of CDTR after administration of CDTR-PI to children (ages between 1 and 10) were investigated. Five cases were administrated with CDTR-PI at a dose level of 3 mg/kg 30 minutes after meal. Serum concentrations in these cases reached their peaks at 2 hours after administration with an average level of 1.23 +/- 0.34 micrograms/ml and diminished to 0.04 +/- 0.04 micrograms/ml at 8 hours after administration with a half-life of 1.60 +/- 0.38 hours. Urinary recovery rates of CDTR in the first 8 hours after administration of CDTR-PI averaged 14.9 +/- 0.9%. Five cases were administered with CDTR-PI at a dose level of 6 mg/kg 30 minutes after meal. Serum concentrations with the drug after meal reached their peaks at 1 hour after administration with an average level of 2.62 +/- 0.42 micrograms/ml and diminished to 0.21 +/- 0.11 micrograms/ml at 8 hours after administration with a half-life of 1.58 +/- 0.31 hours. Urinary recovery rates of CDTR in the first 8 hours after administration of CDTR-PI averaged 17.0 +/- 0.7%. These data also showed that serum and urinary concentrations of the drug depended on dose levels. 2. CDTR-PI was administered to 31 pediatric patients (their ages ranged between 1 year and 10 years) with various infections, and clinical and bacteriological effects and adverse reactions were investigated. Clinical effects were evaluable in 24 cases including 2 cases of scarlet fever, 1 case of acute pharyngitis, 12 cases of acute purulent tonsillitis, 4 cases of acute bronchitis, 5 cases of acute pneumonia. Clinical responses were excellent in 16 cases, effective in 8 cases, with an efficacy rate of 100%. Antimicrobial effects against a total of 16 strains identified or assumed to be pathogenic bacteria were evaluated. The 16 strains of bacteria included 4 strains of Staphylococcus aureus, 6 strains of Streptococcus pyogenes, 2 strains of beta-Streptococcus, 4 strains of Haemophilus influenzae. All the bacteria listed here were judged to have been eradicated except 2 strains of H. influenzae (1 was decreased and 1 was unchanged) thus, the eradication rate was 87.5%. Two strains of bacteria replaced infection causing bacteria. Streptococcus pneumoniae replaced S. pyogenes and S. aureus replaced H. influenzae. No adverse side reactions were observed.(ABSTRACT TRUNCATED AT 400 WORDS)