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NCT03572049 · ClinicalTrials.gov registry record · Phase 2
Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole
A Phase 2 study of Invasive Fungal Infections, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 12
- Study locations
NCT03572049: Completed Phase 2 study of Invasive Fungal Infections, sponsored by University of Alabama at Birmingham.
NCT03572049 is a Phase 2 study of Invasive Fungal Infections that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 88 participants, above the 30-participant average among 4 other Invasive Fungal Infections trials with a reported enrollment target (193% higher). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03572049, a Phase 2 study of Invasive Fungal Infections, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 12
- Study locations
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).
Primary Outcome
Percentage of participants 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
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 |
What the finished NCT03572049 record still lists
NCT03572049 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, above the 30-participant average among 4 other Invasive Fungal Infections trials with a reported enrollment target (193% higher).
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.
NCT03572049 lists 12 locations in 11 states (Illinois, Alabama, Arizona).
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.
What interventions are being tested in trial NCT03572049?
The interventions under investigation include: SUBA itraconazole (DRUG), Conventional itraconazole (DRUG).
Who is sponsoring clinical trial NCT03572049?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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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