Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001280
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
Status:
COMPLETED
Status Verified Date:
2000-02
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:
This protocol describes a prospective randomized study examining the safety and efficacy of Itraconazole for preventing fungal infections in patients with Chronic Granulomatous Disease CGD CGD is a genetic disorder in which phagocytes are unable to produce oxygen radicals As a result affected patients are prone to recurrent severe infections with bacterial and fungal organisms Patients with CGD of 5 or more years of age without evidence of infection at the time of study entry will be eligible for enrollment Patients will be randomized to receive itraconazole or placebo tablets daily in a double blinded fashion In addition to itraconazole all patients will receive antimicrobial prophylaxis against bacterial infection and may in addition receive gamma-interferon as prophylaxis against infection Randomization of patients will be stratified among patients receiving or not receiving gamma interferon The primary endpoint of the study will be the development of culture or histologically proved invasive fungal disease Patients will be monitored every three months for evidence of drug toxicity The anticipated accrual period will be approximately 36-48 months
Detailed Description:
This protocol describes a prospective randomized study examining the safety and efficacy of Itraconazole for preventing fungal infections in patients with Chronic Granulomatous Disease CGD CGD is a genetic disorder in which phagocytes are unable to produce oxygen radicals As a result affected patients are prone to recurrent severe infections with bacterial and fungal organisms Patients with CGD of 5 or more years of age without evidence of infection at the time of study entry will be eligible for enrollment Patients will be randomized to receive itraconazole or placebo tablets daily in a double blinded fashion In addition to itraconazole all patients will receive antimicrobial prophylaxis against bacterial infection and may in addition receive gamma-interferon as prophylaxis against infection Randomization of patients will be stratified among patients receiving or not receiving gamma interferon The primary endpoint of the study will be the development of culture or histologically proved invasive fungal disease Patients will be monitored every three months for evidence of drug toxicity and surveillance cultures of nasopharynx and stool will be obtained The anticipated accrual period will be approximately 36-48 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 91-I-0064 | None | None | None |