Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole
Public ClinicalTrials.gov record NCT03572049. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
SUBA-itraconazole Versus Conventional Itraconazole in the Treatment of Endemic Mycoses: a Multi-center, Open-label Comparative Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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, tolerability and health economics of oral SUBA-itraconazole compared to conventional itraconazole. Patients will receive randomized open-label study drug (SUBA-itraconazole or conventional itraconazole) over a 42 day period and then continue therapy until Day 180. Patients will be stratified based on clinically reported infection with the human immunodeficiency virus (HIV).
Study identification
- NCT ID
- NCT03572049
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 88 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 19 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 17, 2018 (Actual)
- Primary completion
- May 31, 2021 (Actual)
- Completion
- Apr 29, 2022 (Actual)
- Last update posted
- Jul 7, 2023
2018 – 2022
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| University of California at Davis | Sacramento | California | 95817 | — |
| Rush University | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Metro Infectious Disease Associates | Overland Park | Kansas | 66211 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Unniversity of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Washington University in St. Louis | St Louis | Missouri | 63130 | — |
| Duke University Medical Center | Durham | North Carolina | 27710-1000 | — |
| University of Wisconsin | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03572049, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 7, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03572049 live on ClinicalTrials.gov.