Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
Primary Purpose
Mycoses
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
itraconazole
Sponsored by
About this trial
This is an interventional treatment trial for Mycoses focused on measuring Aspergillosis, Phagocyte Defect, Torulopsis, Chronic Granulomatous Disease
Eligibility Criteria
Documented chronic granulomatous disease more than 5 years of age. No fungal infection within the past year. Not currently on other antifungals or have taken other antifungals during the past 3 months. Not currently on phenytoin or rifampin. Negative pregnancy test within 2 weeks of starting protocol.
Sites / Locations
- National Institute of Allergy and Infectious Diseases (NIAID)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001280
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00001280
Brief Title
Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
Official Title
Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
January 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoses
Keywords
Aspergillosis, Phagocyte Defect, Torulopsis, Chronic Granulomatous Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
itraconazole
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Documented chronic granulomatous disease more than 5 years of age.
No fungal infection within the past year.
Not currently on other antifungals or have taken other antifungals during the past 3 months.
Not currently on phenytoin or rifampin.
Negative pregnancy test within 2 weeks of starting protocol.
Facility Information:
Facility Name
National Institute of Allergy and Infectious Diseases (NIAID)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2848442
Citation
Hardin TC, Graybill JR, Fetchick R, Woestenborghs R, Rinaldi MG, Kuhn JG. Pharmacokinetics of itraconazole following oral administration to normal volunteers. Antimicrob Agents Chemother. 1988 Sep;32(9):1310-3. doi: 10.1128/AAC.32.9.1310.
Results Reference
background
PubMed Identifier
6227266
Citation
Gallin JI, Buescher ES, Seligmann BE, Nath J, Gaither T, Katz P. NIH conference. Recent advances in chronic granulomatous disease. Ann Intern Med. 1983 Nov;99(5):657-74. doi: 10.7326/0003-4819-99-5-657.
Results Reference
background
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Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
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