Trial · NCT01562132
Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection
NCT01562132, Phase 2, Terminated, Yale University; results first posted 2015-08-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection. Trials, record NCT01562132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01562132
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection
- NCT number
- NCT01562132
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Cryptococcal Infection Disseminated
- Interventions
- Flucytosine and fluconazole, Fluconazole
- First posted
- 2012-03-23
- Last updated
- 2021-09-29
- Results first posted
- 2015-08-31
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Alive at 12 Weeks | 12 weeks | |
| Secondary | Number of Participants Alive at 2 Weeks | 2 weeks | |
| Secondary | Survival at 24 Weeks | 24 weeks | |
| Secondary | Number of Individuals Who Develop Cryptococcal Meningitis | 24 weeks | Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF. Clinical meningitis will be defined as: * fever\>39.0°C, AND * severe headache, AND At least one of the following: * meningismus, * photophobia, * new onset seizure, * focal neurological deficit localizable to the central nervous system * papilledema * confusion, delirium, or decreased level of consciousness. |
| Secondary | Number of Individuals Who Develop Immune Reconstitution Inflammatory Syndrome Due to Cryptococcus | 24 weeks | Individuals who develop clinical meningitis without evidence of fungal, bacterial, or parasitic (e.g. malaria) organisms in the cerebrospinal fluid. Clinical meningitis will be defined as: * fever\>39.0°C, AND * severe headache, AND * At least one of the following: * meningismus, * photophobia, * new onset seizure, * focal neurological deficit localizable to the central nervous system * papilledema * confusion, delirium, or decreased level of consciousness. |
| Secondary | Achieve Targeted Recruitment, Retention and Adherence Rates | 24 weeks | |
| Secondary | Proportion of Individuals Requiring Treatment Discontinuation | 4 weeks | |
| Secondary | Proportion of Individuals Requiring Dose Reduction | 24 weeks | |
| Secondary | Number of Individuals With Treatment Related Adverse Events | 24 weeks | |
| Secondary | Number of Individuals With Treatment Related Serious Adverse Events | 24 weeks |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Alive at 12 Weeks | 12 weeks | participants | NUMBER | |
| SECONDARY | Number of Participants Alive at 2 Weeks | 2 weeks | |||
| SECONDARY | Survival at 24 Weeks | 24 weeks | |||
| SECONDARY | Number of Individuals Who Develop Cryptococcal Meningitis | 24 weeks | |||
| SECONDARY | Number of Individuals Who Develop Immune Reconstitution Inflammatory Syndrome Due to Cryptococcus | 24 weeks | |||
| SECONDARY | Achieve Targeted Recruitment, Retention and Adherence Rates | 24 weeks | |||
| SECONDARY | Proportion of Individuals Requiring Treatment Discontinuation | 4 weeks | |||
| SECONDARY | Proportion of Individuals Requiring Dose Reduction | 24 weeks | |||
| SECONDARY | Number of Individuals With Treatment Related Adverse Events | 24 weeks | |||
| SECONDARY | Number of Individuals With Treatment Related Serious Adverse Events | 24 weeks |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Alive at 12 Weeks | 5FC Plus Fluconazole | 2 | participants | ||
| Number of Participants Alive at 12 Weeks | Fluconazole Alone | 2 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5FC Plus Fluconazole | 3 | |
| Overall Study | STARTED | Fluconazole Alone | 3 | |
| Overall Study | COMPLETED | 5FC Plus Fluconazole | 3 | |
| Overall Study | COMPLETED | Fluconazole Alone | 3 | |
| Overall Study | NOT COMPLETED | 5FC Plus Fluconazole | 0 | |
| Overall Study | NOT COMPLETED | Fluconazole Alone | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Neutropenia | Blood and lymphatic system disorders | 5FC Plus Fluconazole | 2 | 3 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Fluconazole Alone | 1 | 3 | 1 |
| other | Unintentional Weight Loss | General disorders | 5FC Plus Fluconazole | 1 | 3 | 1 |
| other | Unintentional Weight Loss | General disorders | Fluconazole Alone | 0 | 3 | 0 |
| other | Nausea | Gastrointestinal disorders | 5FC Plus Fluconazole | 0 | 3 | 0 |
| other | Nausea | Gastrointestinal disorders | Fluconazole Alone | 1 | 3 | 1 |
| other | Vomiting | Gastrointestinal disorders | 5FC Plus Fluconazole | 0 | 3 | 0 |
| other | Vomiting | Gastrointestinal disorders | Fluconazole Alone | 1 | 3 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5FC Plus Fluconazole | ||
| Total, all-cause mortality | Fluconazole Alone | ||
| Total, other adverse events | 5FC Plus Fluconazole | 3 | 3 |
| Total, other adverse events | Fluconazole Alone | 2 | 3 |
| Total, serious adverse events | 5FC Plus Fluconazole | 0 | 3 |
| Total, serious adverse events | Fluconazole Alone | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21NS077858 | Targeted Treatment of Early Cryptococcal Infection in HIV-infected Patients | MEYER, ANA-CLAIRE LEW | YALE UNIVERSITY | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2011 to 2012 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 5FC Plus Fluconazole vs Fluconazole Alone: Number of Participants Alive at 12 Weeks | Trial comparisons |
| 5FC Plus Fluconazole vs Fluconazole Alone: 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.
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/NCT01562132
GET https://conductscience.org/api/trials/v1/NCT01562132/registered