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Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001280
  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 II

Genetics Home Reference related topics: L1 syndrome
MedlinePlus related topics: Fungal Infections Molds
Drug Information available for: Itraconazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy Study
Official Title: Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 100
Study Start Date: January 1991
Estimated Study Completion Date: March 2001
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001280

Locations
United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 910064, 91-I-0064
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001280  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Aspergillosis
Phagocyte Defect
Torulopsis
Chronic Granulomatous Disease

Study placed in the following topic categories:
Clotrimazole
Hematologic Diseases
Miconazole
Tioconazole
Aspergillosis
Leukocyte Disorders
Hydroxyitraconazole
Itraconazole
Granuloma
Immunologic Deficiency Syndromes
Mycoses
Lymphatic Diseases
Genetic Diseases, Inborn
Granulomatous Disease, Chronic
Genetic Diseases, X-Linked
Lymphoproliferative Disorders
Chronic granulomatous disease
Torulopsis

Additional relevant MeSH terms:
Phagocyte Bactericidal Dysfunction
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pathologic Processes
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009