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[A clinical study on cefpodoxime proxetil dry syrup in pediatric infections]
Y Wagatsuma1, A Takase, N Fukushima
1Department of Pediatrics, Sapporo City General Hospital.
Insights
Cefpodoxime proxetil dry syrup shows good clinical response in pediatric patients with bacterial infections. The antibiotic demonstrated a 72.7% pathogen eradication rate with minimal side effects, making it a viable treatment option.
Area of Science:
- Pediatric infectious diseases
- Pharmacokinetics and pharmacodynamics
- Antibiotic efficacy
Context:
- Cefpodoxime proxetil (CPDX-PR) is an oral third-generation cephalosporin antibiotic.
- Pediatric clinical studies are essential for evaluating antibiotic safety and efficacy in children.
- Dry syrup formulations enhance medication adherence in pediatric populations.
Purpose:
- To evaluate the clinical efficacy and safety of cefpodoxime proxetil dry syrup in pediatric patients.
- To assess the pharmacokinetic profile (Cmax, T1/2) of cefpodoxime proxetil in children.
- To determine the bacteriological eradication rates of cefpodoxime proxetil against common pediatric pathogens.
Summary:
- Pharmacokinetic analysis in two pediatric subjects showed Cmax values of 5.0 µg/ml (2.13 hr T1/2) and 4.04 µg/ml (1.63 hr T1/2).
- Clinical response was favorable in 21 out of 22 patients (95.5%) diagnosed with bacterial pharyngitis, tonsillitis, scarlet fever, and urinary tract infections.
- Bacteriological efficacy demonstrated an 8/11 (72.7%) pathogen eradication rate. One case of loose stool was the only reported side effect, not requiring treatment discontinuation.
Impact:
- Cefpodoxime proxetil dry syrup exhibits significant clinical effectiveness and a favorable safety profile for treating common pediatric bacterial infections.
- The study supports the use of cefpodoxime proxetil dry syrup as a therapeutic option in pediatric infectious disease management.
- Pharmacokinetic data provides valuable insights for dosing strategies in pediatric populations.
Abstract:
Clinical studies on cefpodoxime proxetil (CS-807, CPDX-PR) dry syrup were carried out in the field of pediatrics, and the results are summarized as follows. 1. Eleven year-old male and 12 year-old female were administered orally at a dose level of 5.6 and 6.0 mg/kg, respectively, after or before meal. Cmax and T1/2 were 5.0 micrograms/ml and 2.13 hours, respectively, for the male and 4.04 micrograms/ml and 1.63 hours, respectively, for the female. 2. Good clinical responses were obtained in 21 of 22 child patients with bacterial pharyngitis, tonsillitis, scarlet fever and urinary tract infections. One child with Mycoplasma pneumonia did not respond. As to bacteriological effects, eradication of pathogens was observed in 8 out of 11 strains, showing an eradication rate of 72.7%. 3. As to side effect, 1 case of loose stool was observed, but there was no need of discontinuing the drug treatment.