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Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
This study has been completed.
Study NCT00001280   Information provided by National Institutes of Health Clinical Center (CC)
First Received: November 3, 1999   Last Updated: March 3, 2008   History of Changes

November 3, 1999
March 3, 2008
January 1991
 
 
 
Complete list of historical versions of study NCT00001280 on ClinicalTrials.gov Archive Site
 
 
 
Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease

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.

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.

Phase II
Interventional
Treatment, Safety/Efficacy Study
Mycoses
Drug: itraconazole
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
100
March 2001
 

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.

Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001280
 
910064, 91-I-0064
National Institute of Allergy and Infectious Diseases (NIAID)
 
 
National Institutes of Health Clinical Center (CC)
February 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP