Clinical trialNCT03572049CompletedPhase 2/PHASE3Interventional

Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole

SponsorUniversity of Alabama at BirminghamEnrollment88Invasive Fungal Infections

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Andrej Spec, MD
Washington University School of Medicine
Principal Investigator
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George R Thompson, MD
University of California, Davis
Study Chair
clinicaltrials.gov ↗
Peter G Pappas, MD
University of Alabama at Birmingham
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Panama

Hospital Santo Tomás
Panama City, Panama

United States

University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
University of California at Davis
Sacramento, California, United States
Rush University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Metro Infectious Disease Associates
Overland Park, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Unniversity of Minnesota
Minneapolis, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Wisconsin
Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Conventional itraconazoleSUBA itraconazole

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Sept 2018
Primary completion: 31 May 2021
Completion: 29 Apr 2022
Last update posted: 7 Jul 2023
Registered enrollment: 88
Registry id: NCT03572049

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.