Infection Clinical Trial
Official title:
Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia
RATIONALE: Anidulafungin may be effective in preventing fungal infections in
immunocompromised children who have neutropenia.
PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how
well it works in preventing fungal infections in immunocompromised children with neutropenia
caused by chemotherapy or aplastic anemia.
OBJECTIVES:
- Determine the safety, tolerability, and pharmacokinetics of anidulafungin in
immunocompromised children with neutropenia.
- Determine the frequency of deeply invasive fungal infections in children receiving this
drug for early empirical therapy.
OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to
1 of 2 groups according to age (2 to 11 years vs 12 to 17 years).
Patients receive anidulafungin IV once daily over 45-120 minutes. In both groups, cohorts of
6 patients receive escalating doses of anidulafungin. Treatment continues for up to 28 days
or until patients recover from neutropenia or become eligible for standard empirical
antifungal therapy in the absence of unacceptable toxicity or breakthrough fungal infection.
Patients are followed at 7-9 days.
PROJECTED ACCRUAL: A total of 25 patients (approximately 12 per group) were accrued for this
study.
;
Masking: Open Label, Primary Purpose: Supportive Care
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