TABLE 1

Demographic features of enrollees by dosage groupa

ParameterValue for treatment group
2.5 mg/kg (n = 10)5.0 mg/kg (n = 13)7.5 mg/kg (n = 12)10 mg/kg (n = 12)
Mean age (yr) ± SD6.8 ± 4.97.7 ± 4.08.3 ± 6.28.2 ± 5.1
No. of male patients:no. of female patients7:39:48:48:4
No. of patients with reason for enrollment
    Empirical antifungal therapy1091110
    Documented invasive fungal infection04b1b0
Median duration of study drug (days) (range)14.5 (3–29)12 (2–27)5 (1–33)7.5 (1–42)
  • a There were 40 patients, with 47 enrollments, in this study. Two patients in the 5-mg/kg group and 3 patients in the 7.5-mg/kg group were previously enrolled in the lower-dosage group. Two patients in the 10-mg/kg group were previously enrolled in the group with the same dosage level of 10 mg/kg.

  • b Four patients enrolled in the 5-mg/kg dosage cohort had documented invasive fungal infections consisting of one case each of fungemia due to Candida albicans and C. parapsilosis, one case of pulmonary aspergillosis due to Aspergillus fumigatus, and one case of cryptococcal meningitis. One patient in the 7.5-mg/kg cohort had documented candidal pneumonia due to C. albicans.