Trial · NCT03572049

Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole

NCT03572049, Phase 2, Phase 3, Completed, University of Alabama at Birmingham; results first posted 2022-10-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole. Trials, record NCT03572049. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03572049

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole
NCT number: NCT03572049
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 88 participants, actual
Lead sponsor: University of Alabama at Birmingham
Conditions: Invasive Fungal Infections
Interventions: SUBA itraconazole, Conventional itraconazole
First posted: 2018-06-28
Last updated: 2023-07-07
Results first posted: 2022-10-06

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 14	Day 14	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
Primary	Frequency of Treatment Related Adverse Events Days 1-42	Day 42	Comparison of the number of treatment related adverse events in each arm occurring Days 1-42.
Secondary	Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 42	Day 42	Percentage of patients with therapeutic itraconazole and hydroxyitraconazole levels as measured in plasma trough levels Day 42
Secondary	Resolution of Signs and Symptoms of Invasive Fungal Infection on Day 42	Day 42	We will measure specific signs and symptoms related to endemic fungal infection, comparing baseline findings to Day 42 findings using physical examination and patient history.
Secondary	The Number of Days of Hospitalization at Day 180	Day 180	The number of days of Hospitalization occurring between Day 1-180

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 14	Day 14	percentage of participants	NUMBER
PRIMARY	Frequency of Treatment Related Adverse Events Days 1-42	Day 42	adverse events	NUMBER
SECONDARY	Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 42	Day 42	percentage of participants	NUMBER
SECONDARY	Resolution of Signs and Symptoms of Invasive Fungal Infection on Day 42	Day 42	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Days of Hospitalization at Day 180	Day 180	Days	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 14	SUBA Itraconazole	60.5		percentage of participants
Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 14	Conventional Itraconazole	71.0		percentage of participants
Frequency of Treatment Related Adverse Events Days 1-42	SUBA Itraconazole	15		adverse events
Frequency of Treatment Related Adverse Events Days 1-42	Conventional Itraconazole	27		adverse events
Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 42	SUBA Itraconazole	69.3		percentage of participants
Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 42	Conventional Itraconazole	58.0		percentage of participants
Resolution of Signs and Symptoms of Invasive Fungal Infection on Day 42	SUBA Itraconazole	29		Participants
Resolution of Signs and Symptoms of Invasive Fungal Infection on Day 42	Conventional Itraconazole	30		Participants
The Number of Days of Hospitalization at Day 180	SUBA Itraconazole	5	Full Range 0 to 50	Days
The Number of Days of Hospitalization at Day 180	Conventional Itraconazole	7	Full Range 0 to 50	Days

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SUBA Itraconazole	42
Overall Study	STARTED	Conventional Itraconazole	46
Overall Study	COMPLETED	SUBA Itraconazole	33
Overall Study	COMPLETED	Conventional Itraconazole	35
Overall Study	NOT COMPLETED	SUBA Itraconazole	9
Overall Study	NOT COMPLETED	Conventional Itraconazole	11

Source ClinicalTrials.gov

Adverse events100

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Weight Gain	General disorders	SUBA Itraconazole	2	42	3
other	Weight Gain	General disorders	Conventional Itraconazole	0	46	0
other	Weakness	General disorders	SUBA Itraconazole	4	42	4
other	Weakness	General disorders	Conventional Itraconazole	0	46	0
other	Rash	General disorders	SUBA Itraconazole	3	42	3
other	Rash	General disorders	Conventional Itraconazole	4	46	4
other	Pruritus	General disorders	SUBA Itraconazole	3	42	3
other	Pruritus	General disorders	Conventional Itraconazole	0	46	0
other	Night sweats	General disorders	SUBA Itraconazole	2	42	3
other	Night sweats	General disorders	Conventional Itraconazole	0	46	0

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SUBA Itraconazole	1	42
Total, all-cause mortality	Conventional Itraconazole	0	46
Total, other adverse events	SUBA Itraconazole	16	42
Total, other adverse events	Conventional Itraconazole	22	46
Total, serious adverse events	SUBA Itraconazole	4	42
Total, serious adverse events	Conventional Itraconazole	12	46

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32457106	DERIVED	PubMed
38440302	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
SUBA Itraconazole vs Conventional Itraconazole: Resolution of Signs and Symptoms of Invasive Fungal Infection on Day 42	Trial comparisons
SUBA Itraconazole vs Conventional Itraconazole: deaths from any cause	Trial comparisons
SUBA Itraconazole vs Conventional Itraconazole: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03572049

GET https://conductscience.org/api/trials/v1/NCT03572049/events?page=2

API reference For AI assistants