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Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole

NCT03572049 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2023-07-07

Study results available
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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

  • Invasive Fungal Infections

Interventions

DRUG

SUBA itraconazole

SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.

DRUG

Conventional itraconazole

Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Peter G Pappas, MD · University of Alabama at Birmingham

  • George R Thompson, MD · University of California, Davis

  • Andrej Spec, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2021-05-31
Completion
2022-04-29
FDA Drug
Yes

Countries

  • United States
  • Panama

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03572049 on ClinicalTrials.gov