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[Pharmacokinetic, bacteriological and clinical studies on biapenem (L-627) in children]
T Tajima1, R Niimi, M Kobayashi
1Department of Pediatrics, Teikyo University, School of Medicine.
Insights
Biapenem (L-627) demonstrated 100% clinical efficacy in treating 10 pediatric bacterial infections, including meningitis and pneumonia. This novel antibiotic showed no adverse reactions and successfully eradicated causative pathogens.
Area of Science:
- Infectious Diseases
- Pharmacology
- Pediatrics
Background:
- Bacterial infections pose a significant threat to pediatric populations.
- Novel antimicrobial agents are crucial for combating resistant pathogens and improving treatment outcomes.
- Biapenem (L-627) is a carbapenem antibiotic with potential broad-spectrum activity.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of biapenem (L-627) in pediatric patients with various bacterial infections.
- To assess the pharmacokinetic profile of biapenem (L-627) in children, including its penetration into cerebrospinal fluid (CSF).
Main Methods:
- A total of 10 pediatric patients with bacterial infections received biapenem (L-627) intravenously.
- Dosing varied based on infection type, ranging from 6 mg/kg three times daily to 40 mg/kg four times daily in meningitis.
- Clinical outcomes, pathogen eradication, and adverse events were monitored over 5-17 days. Pharmacokinetic parameters, including plasma concentrations and CSF penetration, were analyzed.
Main Results:
- Biapenem (L-627) achieved an overall clinical efficacy rate of 100%, with 8 patients showing excellent and 2 showing good responses.
- Seven causative pathogens, including Streptococcus pneumoniae, Moraxella catarrhalis, Haemophilus influenzae, and Pseudomonas aeruginosa, were eradicated.
- No adverse reactions were reported in any of the 10 treated patients. Pharmacokinetic studies indicated therapeutic plasma concentrations and notable CSF penetration.
Conclusions:
- Biapenem (L-627) is a safe and highly effective antibiotic for treating a range of bacterial infections in pediatric patients.
- Its favorable pharmacokinetic profile, including CSF penetration, suggests efficacy in central nervous system infections like meningitis.
- Further investigation into biapenem (L-627) is warranted for its potential role in pediatric infectious disease management.
Abstract:
The results are summarized as follows: 1. A total of 10 patients were treated with biapenem (L-627). We received informed consent from all of their parents. Each dose was 6 mg/kg, and it was administered 3 times daily (40 mg/kg, 4 times daily in meningitis), in a 30-minute intravenous drip infusion for 5-17 days. The clinical efficacies of L-627 in 10 patients with bacterial infections (1 with purulent meningitis, 1 with sepsis, 5 with pneumonia, 2 with urinary tract infection and 1 with purulent tonsillitis) were evaluated as excellent in 8 patients, as good in 2 patients with an efficacy rate of 100%. Seven causative organisms found in 5 patients (Streptococcus pneumoniae in 2, Moraxella (Branhamella) catarrhalis in 2, Haemophilus influenzae in 2 and Pseudomonas aeruginosa in 1) were eradicated. No adverse reaction was observed in any of the 10 patients. 2. Pharmacokinetic studies Peak plasma concentrations of L-627 were 12.5-13.7 micrograms/ml at the dose of 6 mg/kg administered by 30-minute drip infusion. Plasma half-lives of L-627 in the beta-phase averaged 0.72 hour (0.63-0.80 hour). CSF concentration/plasma concentration ratios of L-627 were 1.12/8.16 micrograms/ml (Day 2, 1.17 hours after at dose of 20 mg/kg), 0.88/3.44 micrograms/ml (Day 3, 4.0 hours after at dose of 30 mg/kg) and 0.68/5.12 micrograms/ml (Day 13, 3.0 hours after at dose of 40 mg/kg) administered by 30-minute drip infusion in the child with purulent meningitis (case 1).(ABSTRACT TRUNCATED AT 250 WORDS)