Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis

Prospective, open label study to assess the pharmacokinetics, safety & efficacy of
anidulafungin when used to treat children (aged 1 month - < 18 years) with invasive
candidiasis, including candidemia (ICC). To participate in the study, at the time of
enrollment subjects must (1) have either a confirmed diagnosis of ICC or mycological evidence
highly suggestive of Candida sp or (2) in infants 1 month to < 2 years only, be at high risk
of candidiasis. All subjects meeting screening criteria receive IV anidulafungin. Subjects
will be stratified by age (1 month - < 2 years; 2 years - < 5 years; 5 years - < 18 years).
Subjects may be switched to oral fluconazole, provided that the pre-specified criteria are
met. Subjects with microbiologically confirmed ICC must have a minimum total treatment
duration of 14 days. The maximum allowed treatment duration of anidulafungin is 35 days; the
maximum total treatment duration for the study is 49 days. At selected centers, anidulafungin
pharmacokinetics will be assessed in the first 6 subjects age 1 month - < 2 years to confirm
the recommended dosage regimen. A population PK-PD analysis will be performed in all other
enrolled subjects. Subjects will be followed for safety through 6 week FU visit. Efficacy for
subjects with confirmed ICC will be assessed at EOIVT, EOT, 2-week FU and 6-week FU visits.

Inclusion Criteria:

- Subject must be either (1) at high risk for candidiasis (1 month - < 2 years ONLY) or
(2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC) (All age
groups)

- Male and female patients from 1 month to less than 18 years of age.

Exclusion Criteria:

- Any patients with allergy to the drug; and any pregnant female or lactating.

- Failed previous antifungal therapy or expected to live < 3 days.

- Patients with documented or suspected Candida meningitis.