Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen, LP
Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.
Age
13–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must have:
HIV positive or negative status.
Blastomycosis or histoplasmosis.
Life expectancy of at least 1 week.
You may not be if
Co-existing Condition:
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.
