- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001280
Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
March 3, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Study Overview
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 Type
Interventional
Enrollment
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
-
Bethesda, Maryland, United States, 20892
- National Institute of Allergy and Infectious Diseases (NIAID)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1991
Study Completion
March 1, 2001
Study Registration Dates
First Submitted
November 3, 1999
First Submitted That Met QC Criteria
December 9, 2002
First Posted (Estimate)
December 10, 2002
Study Record Updates
Last Update Posted (Estimate)
March 4, 2008
Last Update Submitted That Met QC Criteria
March 3, 2008
Last Verified
February 1, 2000
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Bacterial Infections and Mycoses
- Leukocyte Disorders
- Phagocyte Bactericidal Dysfunction
- Mycoses
- Granulomatous Disease, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Itraconazole
Other Study ID Numbers
- 910064
- 91-I-0064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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