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[Laboratory and clinical studies on cefteram pivoxil in pediatric field]
1Department of Pediatrics, Aomori Prefectural Central Hospital.
Insights
Cefteram pivoxil (CFTM-PI) demonstrated high efficacy and safety in pediatric bacterial infections. This oral antibiotic achieved a 97.4% clinical efficacy rate with minimal side effects.
Area of Science:
- Pediatric infectious diseases
- Pharmacology and pharmacokinetics
- Antimicrobial chemotherapy
Context:
- Bacterial infections in children require effective and safe oral antibiotic options.
- Understanding the pharmacokinetic profile of antibiotics is crucial for pediatric dosing.
- Cefteram pivoxil (CFTM-PI) is an oral antibiotic investigated for pediatric use.
Purpose:
- To evaluate the pharmacokinetics and clinical efficacy of cefteram pivoxil (CFTM-PI) in children.
- To assess the safety and tolerability of CFTM-PI in a pediatric population.
- To determine the bacteriological eradication rates of CFTM-PI against common pediatric pathogens.
Summary:
- Pharmacokinetic studies showed dose-dependent serum concentrations and consistent urinary recovery rates (29.7%) for CFTM-PI in children.
- Clinical trials involving 38 pediatric patients with bacterial infections reported an overall efficacy rate of 97.4% (18 excellent, 19 good, 1 fair).
- Bacteriological evaluation indicated an 81.8% eradication rate, with notable activity against Streptococcus pyogenes, Streptococcus pneumoniae, and Haemophilus influenzae.
Impact:
- Cefteram pivoxil (CFTM-PI) is confirmed as a useful and safe oral antibiotic for treating pediatric bacterial infections.
- The study supports the use of CFTM-PI in pediatric practice due to its favorable efficacy and safety profile.
- Findings contribute to the evidence base for antimicrobial stewardship in pediatric infectious diseases.
Abstract:
Pharmacokinetic and clinical studies of cefteram pivoxil (CFTM-PI, T-2588) fine granules in children were performed and the following results were obtained. 1. Peak serum concentrations in 4 children given orally a dose of 3 mg/kg and 2 children given orally a dose of 6 mg/kg after meal were reached in 3 to 4 hours and the concentration curves were dependent on dosage levels. The urinary recovery rates up to 8 hours were 29.7% in children given a dose of 3 mg/kg and 29.7% in children given a dose of 6 mg/kg. 2. Clinical efficacies were evaluated in 38 patients with bacterial infections. Twenty seven patients were given each doses of 3 mg/kg in 3 times a day and other 11 patients each doses of 6 mg/kg in 3 times. Clinical effects of CFTM-PI were excellent in 18, good in 19, fair in 1 case, hence the overall clinical efficacy rate was 97.4%. 3. Bacteriologically, 24 strains of causative organisms were isolated. The overall bacteriological eradication rate was 81.8%. Antimicrobial activities were excellent especially against Streptococcus pyogenes, Streptococcus pneumoniae, and Haemophilus influenzae. 4. As for the side effects, slight loose stools were observed in 2 cases, and in laboratory tests, elevations of GOT and GPT were observed in 1 case and an elevation of eosinophil was observed in 1 case. But no one needed any treatment. 5. CFTM-PI is a useful and safe oral antibiotic for the treatment of bacterial infections in pediatrics.