CLINICAL STUDIES OF ARBEKACIN SULFATE IN THE PEDIATRIC FIELD

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. 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.