Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease
Status:
Completed
Trial end date:
2001-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)