Itraconazole for the Prevention of Fungal Infections in Chronic Granulomatous Disease

NCT00001280 | Completed Phase 2

• 2 other identifiers: 91006491-I-0064
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mycoses

Keywords

Aspergillosis; Phagocyte Defect; Torulopsis; Chronic Granulomatous Disease

Interventions

itraconazole DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Hardin TC, Graybill JR, Fetchick R, Woestenborghs R, Rinaldi MG, Kuhn JG. Pharmacokinetics of itraconazole following oral administration to normal volunteers. Antimicrob Agents Chemother. 1988 Sep;32(9):1310-3. doi: 10.1128/AAC.32.9.1310.

  PMID: 2848442 BACKGROUND

• Gallin JI, Buescher ES, Seligmann BE, Nath J, Gaither T, Katz P. NIH conference. Recent advances in chronic granulomatous disease. Ann Intern Med. 1983 Nov;99(5):657-74. doi: 10.7326/0003-4819-99-5-657.

  PMID: 6227266 BACKGROUND

MeSH Terms

Conditions

Mycoses; Aspergillosis; Torulopsis; Granulomatous Disease, Chronic

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Phagocyte Bactericidal Dysfunction; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: January 1, 1991
• Study Completion: March 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-02

Locations

US (1)