Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis
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)
Links
- Source: http://clinicaltrials.gov/show/NCT00004808
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Fluconazole
Triazole antifungal agent that is used to treat oropharyngeal candidiasis and cryptococcal meningitis in AIDS.
Itraconazole
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.
Histoplasmosis
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)
Histoplasma
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.
Antley-bixler Syndrome Phenotype
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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PubMed Articles
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In order to determine whether HIV-associated disseminated histoplasmosis was a recent infection or a reactivation, time series of first episodes of disseminated histoplasmosis were analyzed. Climatic...
Level of Evidence for Therapeutic Drug Monitoring of Fluconazole.
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Histoplasmosis Presenting as a Cutaneous Malignancy of the Eyelid.
Cutaneous histoplasmosis is an uncommon infection and can occur as a primary infection. A manifestation imitating a cutaneous neoplasm is rare, and eyelid involvement is rarer still. The authors repor...
Cystoid Macular Edema Secondary to Fluconazole Toxicity.
Fluconazole is an antifungal commonly used to treat Coccidioides immitis, but this medication has a number of side effects including fatigue, rash, headache, dizziness, nausea, vomiting, diarrhea, and...
Application of nested PCR for diagnosis of histoplasmosis.
Histoplasmosis is a fungal infection that, although not endemic in Japan, has seen a rise in the number of Japanese cases since the mid-1980s. Diagnosis of the disease is not straightforward, and the...
