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[Pharmacokinetic, bacteriological and clinical studies on cefditoren pivoxil in children]
T Tajima1, M Kobayashi, S Negishi
1Department of Pediatrics, School of Medicine, Teikyo University.
Insights
Cefditoren pivoxil (CDTR-PI) demonstrated 100% clinical efficacy in children with bacterial infections, including pneumonia and otitis media. This antibiotic showed good tolerability with minimal side effects in the study.
Area of Science:
- Pediatric infectious diseases
- Antibiotic pharmacokinetics
- Bacteriology
Background:
- Cefditoren pivoxil (CDTR-PI) is a third-generation oral cephalosporin antibiotic.
- Pediatric infections require effective and safe treatment options.
Purpose of the Study:
- To evaluate the pharmacokinetic, bacteriological, and clinical efficacy of cefditoren pivoxil in pediatric patients.
- To assess the safety and tolerability of CDTR-PI in children.
Main Methods:
- A clinical study involving 18 pediatric patients with 19 bacterial infections treated with CDTR-PI.
- Bacteriological evaluation included Minimum Inhibitory Concentration (MIC) testing against isolated strains.
- Pharmacokinetic analysis measured peak serum concentrations of cefditoren (CDTR).
Main Results:
- CDTR-PI achieved a 100% clinical efficacy rate (13 excellent, 6 good) across various infections like pneumonia, otitis media, and sinusitis.
- Eradication of key pathogens including Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus aureus was observed.
- Mild diarrhea was the only reported adverse event, with no severe reactions noted.
Conclusions:
- Cefditoren pivoxil is a safe and effective antibiotic for treating bacterial infections in children.
- The drug demonstrates favorable pharmacokinetic properties and potent bacteriological activity against common pediatric pathogens.
Abstract:
Pharmacokinetic, bacteriological and clinical studies on cefditoren pivoxil (CDTR-PI, ME 1207) were performed in children. The results were as follows: 1. A total of 18 patients (19 infections) were treated with CDTR-PI. The doses ranged 2.1-3.2 mg/kg, and it was orally administered 3 times daily, for 4-10 days. Clinical efficacies of CDTR-PI in 18 patients with 19 bacterial infections (3 with tonsillitis, 1 with bronchitis, 7 with pneumonia, 1 with acute maxillary sinusitis, 4 with otitis media, 1 with urinary tract infection, 2 with skin and soft tissue infection) were evaluated as excellent in 13 infections and as good in 6 infections with an efficacy rate of 100%. Twelve causative strains of 5 species were found in 11 patients. Streptococcus pneumoniae in 2 cases out of 3, Haemophilus influenzae in 4/4, Staphylococcus aureus in 2/2, Haemophilus parainfluenzae in 2/2 and Escherichia coli in 1/1 were eradicated. Two patients had mild diarrhea but did not need specific treatment. Severe adverse reaction was not observed in any of the 18 patients. 2. MICs of CDTR were examined against 4 clinically isolated S. pneumoniae strains. Two strains of S. pneumoniae were relatively resistant to penicillins. 3. Pharmacokinetic studies Peak serum CDTR concentrations in 3 patients were 2.38 micrograms/ml, 0.72 micrograms/ml and 2.25 micrograms/ml at a dose of CDTR-PI 3 mg/kg orally administered at 30-minute after meal.(ABSTRACT TRUNCATED AT 250 WORDS)