Ensayos clínicos

Inclusion Criteria:

• Must have a documented eligible invasive and/or severe fungal disease that is refractory or intolerant to Standard-of-Care treatment. A summary of eligible fungal diseases is listed below:
  • Acute or chronic invasive candidiasis, including candidemia;
  • Acute or chronic severe mucocutaneous candidiasis, including:
  • Esophageal candidiasis, Oropharyngeal candidiasis, Chronic mucocutaneous candidiasis, Vulvovaginal candidiasis;
  • Disseminated/invasive dimorphic fungi: Coccidioidomycosis, Histoplasmosis, Blastomycosis;
  • Chronic Pulmonary Aspergillosis;
  • Allergic Bronchopulmonary Aspergillosis;
  • Invasive Pulmonary Aspergillosis;
  • Other emerging fungi including yeasts and molds (e.g., saccharomycetes, scopulariopsis).
• Be able to tolerate medication orally or through a nasogastric (NG) tube or  percutaneous endoscopic gastrostomy (PEG) tube.
• Be able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
• Be able to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information. (e.g., in  the U.S. HIPAA Authorization form). 
• Be able to understand and follow all study-related procedures including study drug  administration.  
• Agree to use a medically acceptable method of contraception while receiving  protocol-assigned product.  

Exclusion Criteria:

• An invasive fungal disease with CNS involvement.
• Subject has an inappropriately controlled fungal disease source (e.g., persistent  catheters that cannot be removed and are likely the source of infection).
• Subject is hemodynamically unstable, requiring vasopressor medication for blood  pressure support.  
• A life expectancy < 30 days.
• Subject with abnormal liver test parameters: aspartate aminotransferase (AST), alanine  aminotransferase (ALT) > 10 x the upper limit of normal (ULN), and/or total bilirubin > 5 x ULN.
• Subject is pregnant or lactating.
• Subject has used an investigational drug within 30 days prior to the baseline visit.

Eligibility last updated 9/13/21. Questions regarding updates should be directed to the study team contact.