Trial · NCT06414512

Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis

NCT06414512, Phase 2, Completed, University of Minnesota; results first posted 2025-08-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis. Trials, record NCT06414512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06414512

On this page

Trial

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

Title: Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis
NCT number: NCT06414512
Status: Completed
Phases: Phase 2
Enrollment: 48 participants, actual
Lead sponsor: University of Minnesota
Conditions: Cryptococcal Meningitis
Interventions: AMBITION trial control, Flucytosine
First posted: 2024-05-16
Last updated: 2025-08-27
Results first posted: 2025-08-27

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Early Fungicidal Activity	2 weeks	Rate of clearance of Cryptococcus from CSF.
Secondary	CSF Culture Sterility	18 weeks	Cryptococcus is cleared or not from the cerebrospinal fluid
Secondary	Mortality	16 weeks	The proportion of participants who died after 16 weeks follow up

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Early Fungicidal Activity	2 weeks	The number analyzed are lower because not all enrolled had data for these outcomes.	log10 CFU/mL/day	MEAN
SECONDARY	CSF Culture Sterility	18 weeks	The number analyzed are lower because not all enrolled had data for these outcomes.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mortality	16 weeks		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Early Fungicidal Activity	Control	0.39	Standard Deviation 0.27	log10 CFU/mL/day
Early Fungicidal Activity	Low Dose Flucytosine	0.28	Standard Deviation 0.28	log10 CFU/mL/day
CSF Culture Sterility	Control	60		Participants
CSF Culture Sterility	Low Dose Flucytosine	25		Participants
Mortality	Control	50		Participants
Mortality	Low Dose Flucytosine	11		Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Control	171
Overall Study	STARTED	Low Dose Flucytosine	48
Overall Study	COMPLETED	Control	171
Overall Study	COMPLETED	Low Dose Flucytosine	47
Overall Study	NOT COMPLETED	Control	0
Overall Study	NOT COMPLETED	Low Dose Flucytosine	1

Source ClinicalTrials.gov

Adverse events88

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	Creatinine Grade 3 or Worse	Renal and urinary disorders	Control	3	171	3
other	Creatinine Grade 3 or Worse	Renal and urinary disorders	Low Dose Flucytosine	1	48	1
other	Hemoglobin Grade 3 or Worse	Blood and lymphatic system disorders	Control	17	171	17
other	Hemoglobin Grade 3 or Worse	Blood and lymphatic system disorders	Low Dose Flucytosine	7	48	7
other	Elevated Liver Enzymes, Grade 3 or Worse	Hepatobiliary disorders	Control	5	171	5
other	Elevated Liver Enzymes, Grade 3 or Worse	Hepatobiliary disorders	Low Dose Flucytosine	3	48	3
other	Potassium Grade 3 or worse	Metabolism and nutrition disorders	Control	7	171	7
other	Potassium Grade 3 or worse	Metabolism and nutrition disorders	Low Dose Flucytosine	1	48	1
other	Hyponatremia Grade 3 or worse	Metabolism and nutrition disorders	Control	7	171	7
other	Hyponatremia Grade 3 or worse	Metabolism and nutrition disorders	Low Dose Flucytosine	1	48	1

1 to 10 of 88Source ClinicalTrials.gov

See all 88 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Control	50	171
Total, all-cause mortality	Low Dose Flucytosine	11	48
Total, other adverse events	Control	87	171
Total, other adverse events	Low Dose Flucytosine	25	48
Total, serious adverse events	Control	132	171
Total, serious adverse events	Low Dose Flucytosine	31	48

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40795226	DERIVED

Source 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 comparisons4

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

Comparison	Source
Low Dose Flucytosine vs Control: Mortality	Trial comparisons
Low Dose Flucytosine vs Control: CSF Culture Sterility	Trial comparisons
Low Dose Flucytosine vs Control: deaths from any cause	Trial comparisons
Low Dose Flucytosine vs Control: 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/NCT06414512

GET https://conductscience.org/api/trials/v1/NCT06414512/events?page=2

API reference For AI assistants