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[Clinical and pharmacokinetic evaluation of cefodizime in children]
Y Hirabayashi1, H Higashino, M Kino
1Department of Pediatrics, Kansai Medical University.
Insights
Cefodizime (CDZM) demonstrates strong antimicrobial activity, particularly against Haemophilus influenzae, with a high clinical efficacy rate of 81% in pediatric patients. This new cephem antibiotic shows promising results with no observed adverse reactions.
Area of Science:
- Pediatric infectious diseases
- Pharmacology and therapeutics
Background:
- Cefodizime (CDZM) is a novel cephem antibiotic.
- Its clinical utility and pharmacokinetic profile in pediatric populations require thorough investigation.
Observation:
- CDZM exhibited potent in vitro antimicrobial activity against key pediatric pathogens, including Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae, and notably Haemophilus influenzae.
- The minimum inhibitory concentrations (MICs) for CDZM were lower than those of comparator antibiotics like cefotaxime and piperacillin.
- Pharmacokinetic studies revealed a peak serum concentration of 207.80 µg/ml after a 20 mg/kg intravenous infusion, with a half-life of 2.15 hours and significant urinary excretion.
Findings:
- Clinical trials involving 27 pediatric patients with various infections, including pneumonia and urinary tract infections, showed an overall clinical efficacy rate of 81% (5 excellent, 17 good).
- Bacteriological eradication rates reached 85% in 13 assessed cases.
- No adverse reactions were reported in any patient, although transient elevations in liver enzymes were noted in one case.
Implications:
- Cefodizime (CDZM) presents a potentially valuable therapeutic option for pediatric infections due to its potent antimicrobial spectrum and favorable clinical outcomes.
- The favorable safety profile and pharmacokinetic properties support its further evaluation in pediatric populations.
- Further research could explore optimal dosing regimens and expanded indications for CDZM in children.
Abstract:
Cefodizime (CDZM, THR-221), a new cephem antibiotic, was investigated for its clinical efficacy and pharmacokinetics in children. The results obtained are summarized as follows. 1. Antimicrobial activities Antimicrobial activities of CDZM against clinically isolated organisms were determined. MICs of CDZM against 1 strain each of Streptococcus pneumoniae, Escherichia coli and Klebsiella pneumoniae were 0.05 micrograms/ml to 0.10 micrograms/ml. Especially, MIC against all 6 strains of Haemophilus influenzae was less than or equal to 0.024 micrograms/ml. This MIC value was lower than those of other antibiotics such as cefotaxime, cefotiam, cefazolin, piperacillin. 2. Pharmacokinetics CDZM was given to 1 case at a dose of 20 mg/kg by a 60-minute intravenous drip infusion. The peak value of serum concentration of CDZM was 207.80 micrograms/ml at the end of the infusion. The half-life was 2.15 hours. The mean urinary excretion rate was 68.5% in the first 4 hours, 79.2% in 6 hours and 76.5% in 8 hours after the 30-minute drip infusion. 3. Clinical efficacy CDZM was given to a total of 27 patients, 13 with pneumonia, 1 with bronchitis, 2 with acute pharyngitis, 1 with purulent tonsillitis, 5 with urinary tract infection, 1 each with retrograde cholangitis, acute enteritis, pericementitis, phlegmon and inguinal lymphadenitis. Overall clinical efficacies were excellent in 5 cases, good in 17 and the efficacy rate was 81%. Bacteriological effects were investigated in 13 cases and the eradication rate was 85%. No adverse reactions were observed in any case. As abnormal laboratory findings, elevated GOT, GPT, A1-P, LAP and gamma-GTP, were noted in 1 out of the 28 cases examined.