Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mycoses |
Drug: itraconazole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment |
| Official Title: | Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 1991 |
| Estimated Study Completion Date: | March 2001 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00001280 History of Changes |
| Other Study ID Numbers: | 910064, 91-I-0064 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Aspergillosis Phagocyte Defect Torulopsis Chronic Granulomatous Disease |
Additional relevant MeSH terms:
|
Granulomatous Disease, Chronic Mycoses Granuloma Phagocyte Bactericidal Dysfunction Leukocyte Disorders Hematologic Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn Immunologic Deficiency Syndromes Immune System Diseases Lymphoproliferative Disorders |
Lymphatic Diseases Pathologic Processes Itraconazole Hydroxyitraconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013