Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068471
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2003-09-10
Brief Title:
Anidulafungin in Treating Immunocompromised Children With Neutropenia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I-II Study of the Safety Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia
Status:
COMPLETED
Status Verified Date:
2004-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Anidulafungin may be effective in preventing fungal infections in immunocompromised children who have neutropenia
PURPOSE This phase III 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
PURPOSE This phase III 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-03-C-0229C | None | None | None |