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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) National Institute of Allergy and Infectious Diseases (NIAID) University of Alabama at Birmingham |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004808 |
OBJECTIVES: I. Identify a preferred oral fluconazole dose regimen for patients with non-acute histoplasmosis or blastomycosis, or ulcerocutaneous or deep sporotrichosis.
II. Study the safety and efficacy of fluconazole in these patients.
Condition | Intervention | Phase |
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Histoplasmosis Sporotrichosis Blastomycosis |
Drug: fluconazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 78 |
Study Start Date: | September 1991 |
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution and type of infection.
Patients with blastomycosis are randomly assigned to moderate- versus high-dose oral fluconazole. Based on clinical response, the dose is increased at 1 and 2 months for patients in the moderate-dose group. Patients in the high-dose group receive a fixed dose of fluconazole.
Patients with histoplasmosis and sporotrichosis are nonrandomly treated with moderate-dose fluconazole.
Therapy is administered daily for 3 months beyond stabilization of infection (maximum 24 months), or for a total of 6 months if the infection stabilizes within 3 months. Fluconazole may be administered intravenously (maximum 7 days) if the oral dose is not tolerated.
Concurrent systemic or intrathecal antifungals, immunostimulants, and lymphocyte replacement are prohibited. Investigational agents or approved agents given for investigational indications are also not permitted on study.
Patients are followed at 3, 6, and 12 months.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Patient Characteristics--
Study ID Numbers: | 199/12010, NIAID-MSG-13 |
Study First Received: | February 24, 2000 |
Last Updated: | June 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00004808 |
Health Authority: | United States: Federal Government |
blastomycosis fungal infection histoplasmosis |
immunologic disorders and infectious disorders rare disease sporotrichosis |
Fluconazole Mycoses Skin Diseases, Infectious Skin Diseases Clotrimazole Miconazole |
Blastomycosis Histoplasmosis Tioconazole Rare Diseases Sporotrichosis Dermatomycoses |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Infection Pharmacologic Actions |