Randomized comparison between fluconazole and itraconazole for the treatment of candidemia in a pediatric intensive care unit: a preliminary study.

OBJECTIVE: Candida bloodstream infections have shown an increase in hospitalized patients, especially those receiving intensive care. The effectiveness of various azoles, especially itraconazole, in treatment of candidemia has not been fully evaluated. Our objective was to compare the efficacy and safety of enterally administered itraconazole vs. fluconazole in treatment of candidemia.

DESIGN: Randomized, double-blind, controlled trial.

SETTING: Pediatric intensive care unit of a referral and teaching hospital.

SUBJECTS: Forty-three pediatric patients with candidemia,

INTERVENTION: Patients received either fluconazole (n = 22) or itraconazole (n = 21), about 10 mg/kg orally or through a gastric tube, and were monitored for clinical and mycological cure (sterile fungal blood culture), blood counts, and liver and renal functions.

MEASUREMENTS AND MAIN RESULTS: The clinical characteristics of two groups were comparable. The cure rate was similar in both the groups: itraconazole 17 of 21 (81%) and fluconazole 18 of 22 (82%). Crude mortality rate (itraconazole 9.5% and fluconazole 13.6%) was also comparable in two groups of patients. The frequency of electrolyte disturbance was very low and similar in both the groups. Blood urea, creatinine, liver enzymes, and serum bilirubin were not adversely affected.

CONCLUSIONS: Itraconazole was as effective as fluconazole in nosocomial candidiasis in children receiving intensive care and was devoid of serious side effects.