Prospective study to examine the clinical efficacy of vancomycin hydrochloride against pediatric infections caused by methicillin-cephem resistant staphylococcus aureus

Among the few antimicrobial agents approved for the treatment of infections caused by methicillin-cephem resistant Staphylococcus aureus (MRSA), vancomycin hydrochloride (VCM), in particular, has been shown to be safe and effective against MRSA infections when given in appropriate and recommended doses. Although its usefulness in adults has been certified, no adequate studies have yet been conducted to establish the usefulness of VCM in pediatric patients in Japan. We performed a prospective study to examine the usefulness of VCM treatment against pediatric MRSA infections. A total of twenty-one patients were enrolled in the study, each receiving a dose of 10 mg/kg three or four times daily. Both the clinical and bacteriological effects of the drug were evaluated, along with its pharmacokinetic results, and these results were compared with those obtained in adult patients. Clinical effects were evaluated in the fourteen evaluable patients, and results of “excellent” in 5 (35.7%), “good” in 7 (50.0%), and “poor” in 2 (14.3%) were obtained: Bacteriological results were “eliminated” in 10 (71.4%) and “unchanged” in 4 cases (28.6%), in good agreement with the clinical results of preceding studies. Pharmacokinetic analysis showed that almost all the pediatric parameters obtained in this study were nearly identical to those obtained in a preceding adult study where a dose of 0.5 g twice daily was used. The highest serum level attained was 49.1 mcg/ml (mean ± SD=27.4 ± 10.9), which was within recommended levels. No adverse reaction attributable to VCM administration was observed, Slight abnormal changes in laboratory data were observed in three cases: eosinophilia, thrombocytopenia, decrease in serum sodium, urinary protein and hematuria. These results suggest that VCM is both effective and safe in treating pediatric patients with MRSA, when given at a dose of 10 mg/kg three or four times daily.