Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole (NCT03572049) | Clinical Trial Compass
CompletedPhase 2/3
Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole
United States88 participantsStarted 2018-09-17
Plain-language summary
This is a prospective, multi-center, randomized, open-label parallel arm study involving patients with proven or probable invasive endemic fungal infection to ascertain the pharmacokinetics, safety, efficacy, tolerability and health economics of oral SUBA-itraconazole compared to conventional itraconazole. Patients will receive randomized open-label study drug (SUBA-itraconazole or conventional itraconazole) over a 42 day period and then continue therapy until Day 180. Patients will be stratified based on clinically reported infection with the human immunodeficiency virus (HIV).
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Male and female patients age \> 18 years who have given written informed consent to participate
✓. Patients with a proven or probable endemic mycosis (Histoplasma, Coccidioides, Paracoccidioides, Blastomyces, Sporothrix, Talaromyces marneffei (formerly Penicillium marneffei) according to current EORTC/MSG (Mycoses Study Group) criteria, including patients who:
Exclusion criteria
✕. Significant liver dysfunction as evidenced by at least 5 times greater than upper limits of normal baseline ALT (alanine aminotransferase) , AST (aspartate aminotransferase), alkaline phosphatase, or total bilirubin.
✕. Use of an alternative antifungal therapy (IV or oral) for more than 14 days for this infection, with the exception of Coccidioidomycosis. Subjects with Coccidioidomycosis who previously received fluconazole therapy for more than 14 days may be included, if in the opinion of the investigator, they are having an inadequate response or, are intolerant of fluconazole (e.g. due to adverse events). Such subjects must washout from fluconazole for 7 days (\~5 half-lives of fluconazole) before starting investigational therapy.
✕. Evidence of CNS (central nervous system) infection.
✕. Unable to take PO medications.
What they're measuring
1
Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 14
Timeframe: Day 14
2
Frequency of Treatment Related Adverse Events Days 1-42
✕. Female patients who are lactating or pregnant.
✕. Postmenopausal for 1 year,
✕. Post-hysterectomy or bilateral oophorectomy,
✕. If of child bearing potential have a negative β-HCG (human chorionic gonadotropin) at screening and using highly effective method of birth control throughout course of study or remain abstinent for duration of study.