Related Experiment Videos
[Bacteriological, pharmacokinetic and clinical studies on cefteram pivoxil in the pediatric field]
1Department of Pediatrics, Jikei University School of Medicine.
Insights
This study evaluated cefteram pivoxil (CFTM-PI), a new oral cephalosporin, in pediatric patients. CFTM-PI demonstrated strong antibacterial activity and a high clinical efficacy rate of 97.6% with minimal side effects.
Area of Science:
- Pediatric infectious diseases
- Pharmacology and pharmacokinetics
- Antimicrobial resistance
Context:
- Evaluation of a novel oral cephalosporin, cefteram pivoxil (CFTM-PI), for pediatric applications.
- Comparative analysis of CFTM-PI's antibacterial spectrum against common pediatric pathogens.
- Assessment of pharmacokinetic properties including absorption, excretion, and serum concentrations.
Purpose:
- To determine the bacteriological efficacy of CFTM-PI against key pediatric bacterial pathogens.
- To characterize the pharmacokinetic profile of CFTM-PI in pediatric subjects.
- To evaluate the clinical effectiveness and safety of CFTM-PI in treating various pediatric infections.
Summary:
- CFTM-PI exhibited potent in vitro activity against Staphylococcus aureus and Streptococcus pyogenes, showing 2-3 fold greater efficacy than cefaclor or cephalexin.
- Pharmacokinetic studies revealed dose-dependent serum concentrations and half-lives within acceptable ranges for both fasting and non-fasting pediatric patients.
- Clinical trials demonstrated a high overall efficacy rate of 97.6% across 41 pediatric cases, including pneumonia, bronchitis, and urinary tract infections, with eradication of identified bacteria.
Impact:
- CFTM-PI represents a promising new oral cephalosporin for pediatric use, offering effective treatment for common bacterial infections.
- The favorable pharmacokinetic profile and high clinical success rate suggest CFTM-PI's potential to become a valuable therapeutic option in pediatric infectious disease management.
- Further research may explore CFTM-PI's role in combating antibiotic resistance and its long-term safety profile in pediatric populations.
Abstract:
Bacteriological, pharmacokinetic and clinical studies were done on the effect of cefteram pivoxil (CFTM-PI, T-2588) (10% granules), a new oral cephalosporin, in the field of pediatrics. The results are summarized below. 1. Antibacterial activities Antibacterial activities of CFTM against Staphylococcus aureus and Streptococcus pyogenes were studied comparatively with activities of cefaclor (CCL), cephalexin (CEX) and ampicillin (ABPC). MICs of CFTM against S. aureus were distributed in a range between 0.78 and 12.5 micrograms/ml, with a peak value of 3.13 micrograms/ml, which were similar to MIC ranges of CEX and CCL. MICs of CFTM against all strains of S. pyogenes were less than or equal to 0.025 microgram/ml, which were similar to MIC of ABPC. CFTM was approximately 2 to 3 folds more effective than CCL or CEX. 2. Absorption and excretion. Serum concentrations and urinary excretions of CFTM were determined in doses of 3 mg/kg (non-fasting) and 6 mg/kg (non-fasting and fasting). In non-fasting subjects, peak concentrations of CFTM in serum were dose-dependent and were 1.15-2.3 micrograms/ml and 1.8-3.6 micrograms/ml at 2-3 hours, 0.125-0.78 micrograms/ml and 0.245-0.97 micrograms/ml at 6 hours, respectively, for the 2 dose levels. Serum half-lives were 1.03-2.65 hours for the dose of 3 mg/kg and 1.07-1.83 hours for 6 mg/kg. In fasting subjects, the mean peak serum concentrations were 1.73 micrograms/ml at 2 hours and 1.13 micrograms/ml at 6 hours for the dose of 6 mg/kg. Urinary recovery rates in the first 6 hours varied 5.3-19.2%. 3. Clinical study Clinical efficacies were examined in a total of 41 cases including 9 cases of bacterial pneumonia, 10 cases of bronchitis, 11 cases of tonsillitis, 7 cases of urinary tract infections, 3 cases of scarlet fever and 1 case of otitis media. Clinical efficacies were excellent in 30 cases, good in 10 cases, poor in 1 case, hence the efficacy rate was 97.6%. All of the 28 bacteria identified in these cases were eradicated after CFTM-PI treatments. No noticeable abnormalities were found as side effects. An elevation of eosinophil, an increase of platelet count and elevations of GOT and GPT were observed in 3 patients.