Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis

17:52 EST 28th November 2014 | BioPortfolio

Summary

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.

Description

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.

Study Design

Primary Purpose: Treatment

Conditions

Histoplasmosis

Intervention

fluconazole

Status

Completed

Source

Office of Rare Diseases (ORD)

Results (where available)

View Results

Links

Clinical Trials [72 Associated Clinical Trials listed on BioPortfolio]

Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome

To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infe...

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PubMed Articles [102 Associated PubMed Articles listed on BioPortfolio]

Risk Factors for Disseminated Histoplasmosis in a Cohort of HIV-Infected Patients in French Guiana.

Disseminated histoplasmosis is the first AIDS-defining infection in French Guiana. A retrospective cohort study studied predictive factors of disseminated histoplasmosis in HIV-infected patients betwe...

Progressive disseminated histoplasmosis in the HIV population in Europe in the HAART era. Case report and literature review.

In highly endemic areas, up to 20 % of human immunodeficiency virus (HIV)-infected persons will develop progressive disseminated histoplasmosis (PDH). Europe is not endemic to histoplasmosis, and the...

Cutaneous ulcer in an immunosuppressed patient with adult onset Still's disease: primary cutaneous histoplasmosis?

Histoplasmosis is caused by the dimorphic fungus Histoplasma capsulatum.Primary infection occurs through inhalation of spores from the air. Immunocompetent individuals are usually asymptomatic, but ma...

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Pulmonary histoplasmosis is generally a self-limited respiratory illness in endemic areas. Fibrosing mediastinitis is a severe chronic complication of pulmonary histoplasmosis in which pulmonary vesse...

Staging and Response of Sternal Histoplasmosis by 18F-FDG PET/CT.

Histoplasmosis, a granulomatous mycosis caused by the fungus Histoplasma capsulatum, is known to primarily affect the lungs and the immune system, with involvement of skeletal system as a rare manifes...

Medical and Biotech [MESH] Definitions

Triazole antifungal agent that is used to treat oropharyngeal candidiasis and cryptococcal meningitis in AIDS.

One of the triazole ANTIFUNGAL AGENTS that inhibits cytochrome P-450-dependent enzymes resulting in impairment of ERGOSTEROL synthesis. It has been used against histoplasmosis, blastomycosis, cryptococcal meningitis & aspergillosis.

Infection resulting from inhalation or ingestion of spores of the fungus of the genus HISTOPLASMA, species H. capsulatum. It is worldwide in distribution and particularly common in the midwestern United States. (From Dorland, 27th ed)

A mitosporic Onygenales fungal genus causing HISTOPLASMOSIS in humans and animals. Its single species is Histoplasma capsulatum which has two varieties: H. capsulatum var. capsulatum and H. capsulatum var. duboisii. Its teleomorph is AJELLOMYCES capsulatus.

An inherited condition characterized by multiple malformations of CARTILAGE and bone including CRANIOSYNOSTOSIS; midface hypoplasia; radiohumeral SYNOSTOSIS; CHOANAL ATRESIA; femoral bowing; neonatal fractures; and multiple joint CONTRACTURES and, occasionally, urogenital, gastrointestinal or cardiac defects. In utero exposure to FLUCONAZOLE, as well as mutations in at least two separate genes are associated with this condition - POR (encoding P450 (cytochrome) oxidoreductase (NADPH-FERRIHEMOPROTEIN REDUCTASE)) and FGFR2 (encoding FIBROBLAST GROWTH FACTOR RECEPTOR 2).

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