A Study of the Experimental Medicine SUBA-itraconazole Compared to Standard Treatment for Endemic Mycoses (fungal infection)

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Age: 19 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: fungal infection, coccidioidomycoses, endemic mycoses
Type: Drug study, Phase [/2/,/ /3/]
Target:
10 Participants
Investigator:
Description
Treatment of fungal infections can be difficult. The majority require long courses of anti-fungal treatment, often requiring long-term therapy.

This study will determine how safe, effective and well-tolerated an experimental fungal drug, SUBA-itraconazole, is. It will be compared to standard treatment with the drug itraconazole. Standard treatment is the medication normally given to patients with fungal infection.

There are 2 arms (treatment groups) in this research study, ARM A and ARM B. You will be randomized by chance (1:1) to one of the two arms. You have an equal chance to be assigned to either arm.

• ARM A: Open-label study drug treatment by mouth 2 capsules, with food, three times a day for 3 days, then two times a day until day 180

ARM B: Open-label conventional treatment (non-study drug) by mouth 2 capsules, with food, three time a day for 3 days, then two times a day until day 180
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  1. Male and female patients age > 18 years who have given written informed consent to participate
  2. 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:
  3. Are immunosuppressed, including as a result of HIV/AIDS
  4. Have had a heart, lung or bone marrow transplant
  5. Have had chemotherapy for cancer
  6. Are otherwise normal hosts

Exclusion criteria:

  1. 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.
  2. Use of an alternative antifungal therapy (IV or oral) for more than 14 days for this infection.
  3. Evidence of CNS (central nervous system) infection.
  4. Unable to take PO medications.
  5. Female patients who are lactating or pregnant. Women should be:
  6. Postmenopausal for 1 year,
  7. Post-hysterectomy or bilateral oophorectomy,
  8. 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.
  9. Documented intolerance, allergy or hypersensitivity to an azole.
  10. Inability to comply with study treatment, study visits, and study procedures.
  11. Known history of congestive cardiac failure on medical treatment, fungal endocarditis, or other causes of ventricular dysfunction that may outweigh the benefit of itraconazole.
  12. Patients with active TB (tuberculosis)
  13. Concurrent use of astemizole, rifampin/rifampicin, rifabutin, ergot alkaloids, long acting barbiturates, carbamazepine, pimozide, quinidine, neostigmine, terfenadine, ketoconazole, valproic acid, or St. John's wort in the 5 days prior to first administration of study drug.
  14. Any known or suspected condition of the patient that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy.
  15. Treatment with any investigational agent in the 30 days prior to study entry.
  16. Patients unlikely to survive 30 days (including severe fungal disease defined by systolic blood pressure (SBP) < 90; hypoxia < 60).
  17. Patients with body weight < 40 kg.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
We will pay you $50 for each scheduled study visit you complete for your time and effort for a total of $350. Compensation should be provided 1-2 months after your visit in the form of a check mailed to an address that you provide the study team. If you discontinue early, you will be paid only for the visits you completed.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 180 days.
Recruitment period
From July 10, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Catherine Payton
Research Topic
Conditions:
  • Fungal Infection