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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 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.

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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).

Conditions Studied

Invasive Fungal Infections

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

FieldValue
Enrollment Target 88 participants
Start Date 2018-09-17
Est. Completion 2022-04-29
Phase Phase 2

Sponsor

University of Alabama at Birmingham

1,160 total trials

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What the Registry Record Tells You About NCT03572049

The ClinicalTrials.gov registry entry for NCT03572049 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 30-participant average among 4 other Invasive Fungal Infections trials with a reported enrollment target (193% higher). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

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 reports 12 study locations spanning 11 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.