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

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

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

1985-03-31

Brief Summary

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

OBJECTIVES: I. Evaluate the tolerance of patients with blastomycosis, histoplasmosis, and sporotrichosis to different doses of itraconazole (R51,211).

II. Determine levels of itraconazole in serum and other body fluids. III. Assess the course of illness during itraconazole therapy. IV. Determine the dosage of itraconazole that is safe and well tolerated by 80%-90% of patients and estimate the potential of this dosage for use in future comparative trials.

Detailed Description

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

PROTOCOL OUTLINE: This is a study to estimate the optimal dose of oral itraconazole. Patients are treated at 1 of 3 doses of itraconazole; the starting dose for each patient is determined at entry.

Therapy is administered daily for 3-6 months. Patients with progressive disease may be treated at the next higher dose; there may be only 1 such increase. Concurrent systemic and topical antifungals are prohibited.

Patients are followed at 1, 3, 6, and 12 months.

Conditions

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

Histoplasmosis Sporotrichosis Blastomycosis

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

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Culture-proven fungal disease, i.e.: Chronic cavitary histoplasmosis Extrapulmonary histoplasmosis, e.g., mucosal disease Blastomycosis Sporotrichosis Positive culture after last dose of any prior therapy Requires antifungal therapy with amphotericin B or ketoconazole No fungal meningitis No central nervous system disease No immediately life-threatening disease --Prior/Concurrent Therapy-- At least 1 month since therapy for same disease No more than 2 mg/kg prior amphotericin B (total dose) No more than 2 mg/kg prior ketoconazole (total dose) No concurrent immunosuppressives, including: Corticosteroids Azathioprine Cytotoxic agents --Patient Characteristics-- Hepatic: AST no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Bilirubin no greater than 3 mg/dL Other: No acquired immunodeficiency syndrome No pregnant or nursing women Effective contraception required of fertile women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William Dismukes

Role: STUDY_CHAIR

University of Alabama at Birmingham

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIAID-MSG-6A

Identifier Type: -

Identifier Source: secondary_id

199/12013