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Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole
NCT03572049 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG SUBA itraconazole
- DRUG Conventional itraconazole
Study Locations (12)
Illinois
- Rush University — Chicago
- University of Chicago — Chicago
Alabama
- University of Alabama at Birmingham — Birmingham
Arizona
- University of Arizona — Tucson
California
- University of California at Davis — Sacramento
Kansas
- Metro Infectious Disease Associates — Overland Park
Michigan
- University of Michigan — Ann Arbor
Minnesota
- Unniversity of Minnesota — Minneapolis
Missouri
- Washington University in St. Louis — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2022-04-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03572049
The ClinicalTrials.gov registry entry for NCT03572049 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Invasive Fungal Infections appearing as the primary indexed condition, and to 2 interventions — of which SUBA itraconazole is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03572049 reports 12 study locations spanning 11 distinct geographic areas — top geographies include Illinois, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03572049 about?
NCT03572049 is a clinical study titled "Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole". 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 itraco...
What is the current status of trial NCT03572049?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2018-09-17. Estimated completion is 2022-04-29.
What conditions does trial NCT03572049 study?
This clinical trial studies the following conditions: Invasive Fungal Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03572049?
The interventions under investigation include: SUBA itraconazole (DRUG), Conventional itraconazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03572049?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03572049 being conducted?
This trial has 12 study locations across Alabama, Arizona, California, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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