A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
NCT ID: NCT00002159
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Itraconazole
Amphotericin B
Eligibility Criteria
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Inclusion Criteria
* HIV positive or negative status.
* Blastomycosis or histoplasmosis.
* Life expectancy of at least 1 week.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Liver disease.
* Self-limiting fungal disease.
* Very severe fungal disease such as meningeal involvement.
* Acute respiratory disease.
Concurrent Medication:
Excluded at any time:
* Terfenadine.
* Astemizole.
* Oral midazolam.
* Triazolam.
* Cisapride.
* Phenytoin.
* Phenobarbital.
* Rifampin.
* Rifabutin.
Excluded during oral consolidation:
* H2 blockers.
* Chronic antacids.
* Omeprazole.
* Lansoprazole.
Patients with the following prior condition are excluded:
Hypersensitivity to azole antifungals.
Prior Medication:
Excluded at any time:
More than 3 days of amphotericin B, fluconazole, or ketoconazole.
Excluded within 2 weeks prior to study entry:
* Phenytoin.
* Phenobarbital.
* Rifampin.
* Rifabutin.
13 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
Locations
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UAB Station / Infectious Division
Birmingham, Alabama, United States
Univ of Arkansas for Med Sciences
Little Rock, Arkansas, United States
Division of Infectious Diseases
Atlanta, Georgia, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States
Community Hosp
Indianapolis, Indiana, United States
LSU Med Ctr / Div of Pulmonary & Critical Care Med
Shreveport, Louisiana, United States
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, United States
Univ of Missouri / Division of Infectious Diseases
Kansas City, Missouri, United States
Infectious Diseases Association / Research Med Ctr
Kansas City, Missouri, United States
Countries
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Other Identifiers
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ITR-USA-118
Identifier Type: -
Identifier Source: secondary_id
254A
Identifier Type: -
Identifier Source: org_study_id