Trial · NCT01092832
A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients
NCT01092832, Phase 3, Terminated, Pfizer; results first posted 2015-08-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients. Trials, record NCT01092832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01092832
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients
- NCT number
- NCT01092832
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 23 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Candidiasis
- Interventions
- voriconazole
- First posted
- 2010-03-25
- Last updated
- 2016-06-23
- Other registries' IDs
- eudract:2009-012848-16
- Results first posted
- 2015-08-17
- Limitations and caveats
The study was prematurely terminated due to slow enrollment. The study was not terminated due to any safety issues or concerns. Interpretation of the data are limited due to the small sample size and descriptive design.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events - Overall Summary | Baseline up to 1 month follow-up | Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs. |
| Secondary | Percentage of Participants With a Global Response of Success at End of Treatment (EOT) | EOT (from 7 to 42 days of treatment) | Global response was determined programmatically based on investigator assessment of clinical and microbiological response. Global response of success was defined as clinical cure or improvement AND microbiological eradication or presumed eradication. Exact 95 percent (%) confidence interval for binomial proportions using Clopper-Pearson method. |
| Secondary | All-Cause Mortality - Number of Participant Deaths | Day 28 and 1 Month Follow-up | |
| Secondary | Time to Death | Baseline up to 1 month follow-up |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Events - Overall Summary | Baseline up to 1 month follow-up | Safety population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Global Response of Success at End of Treatment (EOT) | EOT (from 7 to 42 days of treatment) | Modified Intent-to-Treat (MITT) Population: all participants who received at least 1 dose of study medication and who have confirmed ICC, EC or participants with EC who do not have confirmation of EC by esophagoscopy, but who had at least confirmation of oropharyngeal candidiasis. | percentage of participants | NUMBER |
| SECONDARY | All-Cause Mortality - Number of Participant Deaths | Day 28 and 1 Month Follow-up | Safety population | participants | NUMBER |
| SECONDARY | Time to Death | Baseline up to 1 month follow-up | No participants died within the safety reporting period, therefore time to death was not applicable. |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events - Overall Summary | Voriconazole: 2 to <12 Years | With AEs | 92.9 | percentage of participants | |
| Percentage of Participants With Adverse Events - Overall Summary | Voriconazole: 12 to <18 Years | With AEs | 75.0 | percentage of participants | |
| Percentage of Participants With Adverse Events - Overall Summary | Voriconazole: 2 to <12 Years | With SAEs | 14.3 | percentage of participants | |
| Percentage of Participants With Adverse Events - Overall Summary | Voriconazole: 12 to <18 Years | With SAEs | 12.5 | percentage of participants | |
| Percentage of Participants With Adverse Events - Overall Summary | Voriconazole: 2 to <12 Years | With severe AEs | 28.6 | percentage of participants | |
| Percentage of Participants With Adverse Events - Overall Summary | Voriconazole: 12 to <18 Years | With severe AEs | 37.5 | percentage of participants | |
| Percentage of Participants With Adverse Events - Overall Summary | Voriconazole: 2 to <12 Years | Discontinued due to AEs | 14.3 | percentage of participants | |
| Percentage of Participants With Adverse Events - Overall Summary | Voriconazole: 12 to <18 Years | Discontinued due to AEs | 25.0 | percentage of participants | |
| Percentage of Participants With Adverse Events - Overall Summary | Voriconazole: 2 to <12 Years | Dose reduced/temporary discontinuation due to AE | 21.4 | percentage of participants | |
| Percentage of Participants With Adverse Events - Overall Summary | Voriconazole: 12 to <18 Years | Dose reduced/temporary discontinuation due to AE | 0 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Voriconazole: 2 to <12 Years | 14 | |
| Overall Study | STARTED | Voriconazole: 12 to <18 Years | 8 | |
| Overall Study | COMPLETED | Voriconazole: 2 to <12 Years | 13 | |
| Overall Study | COMPLETED | Voriconazole: 12 to <18 Years | 8 | |
| Overall Study | NOT COMPLETED | Voriconazole: 2 to <12 Years | 1 | |
| Overall Study | NOT COMPLETED | Voriconazole: 12 to <18 Years | 0 |
Source ClinicalTrials.gov
Adverse events190
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 | Anaemia | Blood and lymphatic system disorders | Voriconazole: 2 to <12 Years | 1 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | Voriconazole: 12 to <18 Years | 0 | 8 | |
| other | Hypothrombinaemia | Blood and lymphatic system disorders | Voriconazole: 2 to <12 Years | 0 | 14 | |
| other | Hypothrombinaemia | Blood and lymphatic system disorders | Voriconazole: 12 to <18 Years | 1 | 8 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Voriconazole: 2 to <12 Years | 1 | 14 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Voriconazole: 12 to <18 Years | 0 | 8 | |
| other | Leukopenia | Blood and lymphatic system disorders | Voriconazole: 2 to <12 Years | 1 | 14 | |
| other | Leukopenia | Blood and lymphatic system disorders | Voriconazole: 12 to <18 Years | 0 | 8 | |
| other | Neutropenia | Blood and lymphatic system disorders | Voriconazole: 2 to <12 Years | 1 | 14 | |
| other | Neutropenia | Blood and lymphatic system disorders | Voriconazole: 12 to <18 Years | 0 | 8 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Voriconazole: 2 to <12 Years | ||
| Total, all-cause mortality | Voriconazole: 12 to <18 Years | ||
| Total, other adverse events | Voriconazole: 2 to <12 Years | 13 | 14 |
| Total, other adverse events | Voriconazole: 12 to <18 Years | 6 | 8 |
| Total, serious adverse events | Voriconazole: 2 to <12 Years | 2 | 14 |
| Total, serious adverse events | Voriconazole: 12 to <18 Years | 1 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27636722 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Voriconazole: 2 to <12 Years vs Voriconazole: 12 to <18 Years: serious adverse events |
Source 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/NCT01092832
GET https://conductscience.org/api/trials/v1/NCT01092832/events?page=2