Status:
WITHDRAWN
SUBA-Itraconazole Therapy for Coccidioidomycosis Refractory or Intolerant to Fluconazole
Lead Sponsor:
George R Thompson
Collaborating Sponsors:
Mayne Pharma International Pty Ltd
Conditions:
Coccidioidomycosis
Valley Fever
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine how safe, effective, and well tolerated a new investigational antifungal drug, SUBA-itraconazole, is for patients who have been previously treated with flucon...
Detailed Description
This is a prospective, multi-center, open-label study involving subjects with proven or probable coccidioidomycosis refractory to fluconazole therapy following \>40 days of treatment or subjects with ...
Eligibility Criteria
Inclusion
- All subjects ≥ 18 years who have given written informed consent to participate
- Subjects with a proven or probable coccidioidomycosis according to current European Organisation for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria, including subjects who:
- Are immunosuppressed, including as a result of HIV/AIDS
- Have had a heart, lung or bone marrow transplant
- Have had chemotherapy for cancer
- Are otherwise not immunocompromised
- Note: central nervous system (CNS) infection is an exclusionary criteria
- Refractory for ≥ 40 days, or intolerant to fluconazole treatment for coccidioidomycosis in the opinion of the investigator
- Refractory disease defined as failure to obtain an adequate therapeutic response after ≥40 days of therapy:
- Lack of improvement in signs, symptoms or imaging findings OR
- Continued isolate of Coccidioides or histopathologic findings of • Coccidioides despite antifungal therapy
- Rising Complement Fixation Titers
- Progression of disease (requires worsening of attributable signs, symptoms or imaging, or a new site of infection
- Intolerance defined as adverse events attributable to fluconazole therapy defined as organ toxicity of grade 3 or higher, nephrotoxicity (Creatinine twice the upper limit of normal), or idiosyncratic reactions therapy that in the opinion of the investigator may be relieved by a therapeutic change OR refusal of the patient to take further fluconazole
- Subjects of childbearing potential should be non-pregnant and not breastfeeding (and not planning to become pregnant)
- Postmenopausal for ≥1 year
- Post-hysterectomy or bilateral oophorectomy
- If of child-bearing potential have a negative pregnancy test at screening and using an acceptable effective method of birth control throughout course of study or remain abstinent for duration of study. Subjects with a partner of childbearing potential should agree to use appropriate contraception.
Exclusion
- Significant liver dysfunction as evidenced by total bilirubin \> 1.5 × the upper limit of normal (ULN) range unless considered due to Gilbert syndrome, in which case \> 3 × the ULN, and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \> 1.5 x the ULN.
- Evidence of CNS infection.
- Unable to take PO medications.
- Documented intolerance, allergy or hypersensitivity to itraconazole.
- Inability to comply with study treatment, study visits, and study procedures.
- Known history or presence of congestive cardiac failure, fungal endocarditis, or other causes of ventricular dysfunction that may outweigh the benefit of itraconazole.
- Subjects with active tuberculosis.
- Concurrent use of drugs that effect SUBA™-itraconazole concentrations
- • Subjects who washout from prohibited medications can be included
- Any known or suspected condition of the subject that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy.
- Treatment with any investigational agent in the 30 days prior to study entry.
- Subjects unlikely to survive 30 days based on the opinion of the investigator.
- Subjects with body weight \< 40 kg.
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04809649
Start Date
May 15 2021
End Date
September 1 2022
Last Update
July 19 2021
Active Locations (1)
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1
University of California, Davis Medical Center
Sacramento, California, United States, 95817