Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-01-31

Study Completion Date

2001-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis

NCT00004811

Histoplasmosis Sporotrichosis Blastomycosis

COMPLETED PHASE1/PHASE2

A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients With AIDS

NCT00000992

HIV Infections Histoplasmosis

COMPLETED PHASE1

Posaconazole to Treat Invasive Fungal Infections

NCT00033982

Granulomatous Disease, Chronic Job's Syndrome Infection

COMPLETED PHASE3

A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis

NCT00002159

HIV Infections Histoplasmosis Blastomycosis

COMPLETED PHASE3

A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients

NCT00002438

HIV Infections Histoplasmosis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mycoses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

itraconazole

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No