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[Clinical studies of cefixime in pediatric field]
Insights
Cefixime (CFIX) demonstrated high efficacy and safety in pediatric patients. This antibiotic achieved excellent therapeutic responses and pathogen eradication with minimal side effects in children treated for bacterial infections.
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Clinical Microbiology
Background:
- Cefixime is a third-generation cephalosporin antibiotic.
- Pediatric dosing and efficacy data for cefixime require further investigation.
Purpose of the Study:
- To evaluate the pharmacokinetic profile and clinical effectiveness of cefixime in children.
- To assess the safety and tolerability of cefixime in a pediatric population.
Main Methods:
- Pharmacokinetic analysis of serum and urinary cefixime concentrations in 6 children (5-14 years) receiving single doses (1.5 or 6.0 mg/kg).
- Clinical efficacy assessment in 43 children with tonsillitis or scarlet fever.
- Microbiological evaluation of pathogen eradication rates.
Main Results:
- Mean serum concentrations peaked at 4 hours, with biological half-lives ranging from 4.45 to 5.28 hours.
- High therapeutic response rate (97.7%) and pathogen eradication rate (93.5%) observed.
- No significant clinical side effects reported; minor laboratory abnormalities in a few patients.
Conclusions:
- Cefixime exhibits favorable pharmacokinetics and demonstrates significant efficacy and safety for treating bacterial infections in children.
- The drug is well-tolerated and effective in pediatric patients with conditions like tonsillitis and scarlet fever.
Abstract:
Pharmacokinetic and clinical studies of cefixime (CFIX) in children were done and the following results were obtained. Serum and urinary concentrations of CFIX were determined in 6 children aged 5 to 14 years given single doses of 1.5 or 6.0 mg/kg. Mean serum concentrations peaked at 4 hours after the administration of either 1.5 or 6.0 mg/kg, and respective peak values were 0.71 and 4.46 micrograms/ml. Biological half-lives for the low and the high doses were 5.28 and 4.45 hours, respectively. The 12-hours urinary recovery ranged from 7.0 to 13.8% after administration of 1.5 mg/kg, and the 8-hours urinary recovery was 18.1% after administration of 6.0 mg/kg. Therapeutic responses were recorded as excellent or good in 43 (97.7%) of the children, comprising 13 with tonsillitis and 31 with scarlet fever. The microbiological effectiveness of CFIX on identified pathogens comprising 29 strains of S. pyogenes and 2 strains of S. aureus was satisfactory as evidence by a high eradication rate of 93.5%. No clinical side effects were observed. Abnormal laboratory findings were elevation of GOT and/or GPT in 4 patients and eosinophilia in 1 patient. In conclusion, CFIX was found to be efficacious and safe for the treatment of bacterial infections in children.