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

Launched by PFIZER · Sep 26, 2008

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• 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.