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 fluconazole and have had either an insufficient response to treatment with fluconazole or a negative reaction to fluconazole preventing their further treatment with it.
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 proven or probable coccidioidomycosis who are intolerant to fluconazole. The availability "Super Bioavailability" (SUBA) itraconazole 65 mg capsules with twice-daily dosing options with improved pharmacokinetics and lack of food or acidity requirements offers a substantial opportunity to improve the treatment of subjects with coccidioidomycosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Participant will receive treatment with SUBA-itraconazole
University of California, Davis Medical Center
Sacramento, California, United States
1. The Proportion of Participants Who Achieve Clinical Improvement, in All Participants Who Took at Least One Dose of Study Drug
Clinical Improvement is defined as at a) at least a 50% reduction in coccidioidomycosis Mycoses Study Group (MSG Score) from baseline value, or b) the unequivocal documentation of clinical improvement as recorded on the progress note of the medical provider, or c) a 25%-49% decrease in the MSG score from baseline value and a physician's impression of improvement as recorded on the progress note. The MSG score is a composite scoring system that has been used in numerous past studies of coccidioidomycosis. This system comprises the sum of points assigned based on the findings of: (1) clinical assessments, (2) radiographic imaging, and (3) serologic assays, with a lower score indicating better health.
Time frame: 180 days
Number of Participants with Treatment-Emergent Adverse Events
Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state. Severity grading will be based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. This is a descriptive scoring system which can be used for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term as follows: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
Time frame: 180 days
Number of Participants with Abnormal Laboratory Evaluations of Safety
Abnormal is defined as at least a 1 grade shift from baseline. Severity grading will be based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. This is a descriptive scoring system which can be used for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term as follows: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
Time frame: 180 days
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Number of Participant Discontinuations of Therapy Due to Treatment-Emergent Adverse Events and/or Laboratory Evaluations of Safety
Number of Participant Discontinuations of Therapy Due to Treatment-Emergent Adverse Events and/or Laboratory Evaluations of Safety
Time frame: 180 days
Number of Participants with Any Interruptions of Therapy due to Treatment-Emergent Adverse Events and/or Abnormal Laboratory Evaluations of Safety
Number of Participants with Any Interruptions of Therapy due to Treatment-Emergent Adverse Events and/or Abnormal Laboratory Evaluations of Safety
Time frame: 180 days
Number of Participants with Interruptions of Therapy 7 Days or More in Duration due to Treatment-Emergent Adverse Events and/or Abnormal Laboratory Evaluations of Safety
Number of Participants with Interruptions of Therapy 7 Days or More in Duration due to Treatment-Emergent Adverse Events and/or Abnormal Laboratory Evaluations of Safety
Time frame: 180 days
Mean, Median, and Quartile Score Values for Mental Component Summary and Physical Component Summary Scores of the SF-12v2 Survey
The Short Form 12 Question Health Survey, version 2 (SF-12v2) is a 12-question multipurpose survey instrument derived from the larger, Short Form 36 Question Survey. The SF-12v2 is to help determine the participant's overall state of wellbeing and health-related quality of life by means of assessing both physical and mental status at the time of the survey. The 8 domains of the survey are: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role- emotional (RE), and mental health (MH). Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions. MCS and PCS values can range from 0 to 100, where a higher score indicates better health.
Time frame: 42 days
Mean, Median, and Quartile Score Values for Mental Component Summary and Physical Component Summary Scores of the SF-12v2 Survey
The Short Form 12 Question Health Survey, version 2 (SF-12v2) is a 12-question multipurpose survey instrument derived from the larger, Short Form 36 Question Survey. The SF-12v2 is to help determine the participant's overall state of wellbeing and health-related quality of life by means of assessing both physical and mental status at the time of the survey. The 8 domains of the survey are: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role- emotional (RE), and mental health (MH). Mental and physical composite scores (MCS \& PCS) are computed using the scores of twelve questions. MCS and PCS values can range from 0 to 100, where a higher score indicates better health.
Time frame: 180 days