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[Clinical studies of arbekacin sulfate in the pediatric field]
1Institute of Chemotherapy for Mother and Child, Asahikawa Medical College.
Unlabelled:
A clinical investigation was carried out to evaluate arbekacin, an aminoglycoside, in the treatment of MRSA infections (pneumonia, septicemia, etc.) of pediatric patients. The obtained results are summarized as follows. 1.
Clinical Results:
Excluding those patients who met the present exclusion criteria and withdrawal cases from a total of 18 patients, 10 patients (3, 6, and 1 cases of septicemia, pneumonia, and urinary tract infection, respectively) were subjected to clinical evaluation. These were composed of 1, 1, 6, and 2 cases of neonate, infants, pre- and school age children, respectively. Excellent, good and fair results were obtained in 5, 2, and 3 patients, respectively; thus, the efficacy rate was 70.0%. The efficacy rate by disease was 100%, 50.0% and 100% in septicemia, pneumonia, and urinary tract infection, respectively. The bacteriological eradication were obtained in 70.0% of the total patients; by disease, these rates were 100% and 50.0% in septicemia/urinary tract infection and in pneumonia, respectively. The MIC50 as well as the MIC80 against MRSA strains isolated from 9 patients were 0.39 microgram/ml and 1.56 micrograms/ml, respectively. No adverse reactions were observed in the 15 patients, while in laboratory test values, one case each out of 12 patients examined showed gamma-GTP elevation, proteinuria, and hematuria. 2. Pharmacokinetics: The pharmacokinetics of the agent was investigated in a total of 9 patients, which included 1 neonate and 4 cases each of pre- and school age children. The Cmax, 4.85-8.83 micrograms/ml, was observed immediately after the termination of the instillation. The T1/2's were 4.96 hours, 1.24-2.54 hours, and 1.78-1.88 hours in the neonate, the pre- and the school age children, respectively; in the neonate the half-life was longer. When 1.92-2.7 mg/kg were administered to 3 each of the pre- and school age children, urinary excretion rates in the first 6-8 hours were 40.1-56.5% of the dosages administered. In all cases, the urinary concentrations were highest in the first 2 hours, after the administration, and then gradually decreased. These results suggest that arbekacin is a useful antibiotic for treating MRSA infections in the pediatric field.
Insights
Arbekacin effectively treated pediatric MRSA infections, showing a 70% efficacy rate with no severe adverse reactions. Pharmacokinetic studies confirmed its utility in neonates and children, suggesting it as a valuable antibiotic option.
Area of Science:
- Clinical microbiology
- Pediatric infectious diseases
- Pharmacology
Background:
- Methicillin-resistant Staphylococcus aureus (MRSA) poses a significant threat in pediatric healthcare settings.
- Aminoglycoside antibiotics are crucial for treating severe bacterial infections, including those caused by MRSA.
Purpose of the Study:
- To evaluate the efficacy and safety of arbekacin in treating pediatric patients with MRSA infections.
- To assess the pharmacokinetic profile of arbekacin in different pediatric age groups.
Main Methods:
- A clinical investigation involving pediatric patients diagnosed with MRSA infections (pneumonia, septicemia, urinary tract infections).
- Evaluation of clinical efficacy, bacteriological eradication rates, and adverse reactions.
- Pharmacokinetic analysis including Cmax, T1/2, and urinary excretion rates in neonates, infants, and children.
Main Results:
- Arbekacin demonstrated a 70% overall efficacy rate in 10 evaluated pediatric patients, with 100% efficacy in septicemia and urinary tract infections, and 50% in pneumonia.
- Bacteriological eradication was achieved in 70% of patients, with higher rates for septicemia/urinary tract infections (100%) compared to pneumonia (50%).
- No adverse reactions were reported in 15 patients; minor laboratory abnormalities (elevated gamma-GTP, proteinuria, hematuria) were observed in a few cases. Pharmacokinetic studies showed a longer half-life in neonates.
Conclusions:
- Arbekacin is a potentially useful antibiotic for treating MRSA infections in pediatric patients.
- The drug exhibits favorable efficacy and safety profiles in the pediatric population.
- Understanding the pharmacokinetics of arbekacin in children is essential for optimizing treatment regimens.