Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole (MSG15)
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|ClinicalTrials.gov Identifier: NCT03572049|
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : February 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fungal Infection||Drug: SUBA itraconazole Drug: Conventional itraconazole||Phase 2 Phase 3|
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, and tolerability of oral SUBA-itraconazole or itraconazole. Patients will receive randomized open-label study drug (either SUBA- itraconazole 130 mg twice daily or itraconazole 200 mg twice daily) over a 42-day period and then continue on their assigned open-label therapy until day 180.
The study sample size will be 80 evaluable patients - target enrollment (three arms: approximately 40 histoplasmosis, 20 coccidioidomycosis, 20 other endemic fungal infections).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||SUBA-itraconazole Versus Conventional Itraconazole in the Treatment of Endemic Mycoses: a Multi-center, Open-label Comparative Trial|
|Actual Study Start Date :||September 17, 2018|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||May 31, 2020|
Experimental: SUBA itraconazole
Stage 1: Day 1-3 two 65 mg capsules three times daily with food. Days 4-42 two 65 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 65 mg capsules twice daily with food
Drug: SUBA itraconazole
SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
Active Comparator: Conventional itraconazole
Stage 1: Day 1-3 two 100 mg capsules three times daily with food. Days 4-42 two 100 mg capsules twice daily with food.
Stage 2 : Days 43-180 two 100 mg capsules twice daily with food
Drug: Conventional itraconazole
Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
- Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole levels at Day 14 [ Time Frame: Baseline to Day 14 ]Time to achieve therapeutic itraconazole and hydroxyitraconazole levels by evaluating Inter-patient variability as calculated by co-efficient of variation on plasma specimens collected on Day 14
- Adherence to study medication regimens Days 1-42 [ Time Frame: Baseline to Day 42 ]The percentage of prescribed capsules returned in capsule count on Day 42
- Frequency of treatment related adverse events Days 1-42 [ Time Frame: Baseline to Day 42 ]Comparison of the number of treatment related adverse events in each arm occurring Days 1-42.
- Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole levels at Day 42 [ Time Frame: Baseline to day 42 ]Percentage of patients with therapeutic itraconazole and hydroxyitraconazole levels as measured in plasma trough levels Day 42
- Resolution of signs and symptoms of invasive fungal infection on Day 42 [ Time Frame: Baseline to day 42 ]We will measure specific signs and symptoms related to endemic fungal infection, comparing baseline findings to Day 42 findings using physical examination and patient history.
- The number of days of Hospitalization at Day 180 [ Time Frame: Baseline to day 180 ]The number of days of Hospitalization occurring between Day 1-180
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572049
|Contact: Alisa Peinhardtfirstname.lastname@example.org|
|Contact: Rachel McMullenemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Alisa Peinhardt, MAIS firstname.lastname@example.org|
|Contact: Rachel McMullen, BS email@example.com|
|Principal Investigator: Peter G Pappas, MD|
|United States, California|
|University of California at Davis||Active, not recruiting|
|Sacramento, California, United States, 95817|
|United States, Illinois|
|Rush University||Active, not recruiting|
|Chicago, Illinois, United States, 60612|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Andrea Woods 734-647-9830 firstname.lastname@example.org|
|Principal Investigator: Marisa Miceli, MD|
|United States, Missouri|
|Washington University in St. Louis||Recruiting|
|Saint Louis, Missouri, United States, 63130|
|Contact: Sara Hubert, RN 314-747-1922 email@example.com|
|Principal Investigator: Andrej Spec, MD|
|United States, Wisconsin|
|University of Wisconsin||Active, not recruiting|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Peter G Pappas, MD||University of Alabama at Birmingham|
|Study Chair:||George R Thompson, MD||University of California, Davis|
|Principal Investigator:||Andrej Spec, MD||Washington University School of Medicine|