Trial · NCT00836875
A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
NCT00836875, Phase 3, Terminated, Pfizer; results first posted 2014-06-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children. Trials, record NCT00836875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00836875
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
- NCT number
- NCT00836875
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Invasive Aspergillosis
- Interventions
- Voriconazole
- First posted
- 2009-02-04
- Last updated
- 2017-06-16
- Other registries' IDs
- eudract:2008-005275-10
- Results first posted
- 2014-06-23
- 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 outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment | |
| Secondary | Percentage of Participants With a Global Response of Success | Weeks 6 and End of Treatment (EOT; up to Week 12) | Percentage of participants with global response of success at Weeks 6 and at EOT (up to Week 12). Global response of success was defined as a participant who achieved a complete or partial global response per the investigator. Complete response was defined as resolution of all clinical signs and symptoms PLUS resolution of 90 percent (%) or more of the lesions visible on radiological studies and attributed to invasive aspergillosis (IA) at Baseline. Partial response was defined as clinical improvement PLUS 50% to \<90% resolution of the radiological lesions attributed to IA at Baseline. |
| Secondary | All-Cause Mortality - Number of Participant Deaths | Week 6 and EOT (up to Week 12) | Number of participant deaths reported at Week 6 and at EOT (up to Week 12). |
| Secondary | Attributable Mortality - Number of Participant Deaths | Weeks 6 and EOT (up to Week 12) | Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12). |
| Secondary | Time to Death | Baseline up to 1 month post treatment |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment | Safety population | participants | NUMBER |
| SECONDARY | Percentage of Participants With a Global Response of Success | Weeks 6 and End of Treatment (EOT; up to Week 12) | Modified intent to treat (MITT) population: all participants receiving at least 1 dose of study drug and diagnosed with proven or probable aspergillosis (defined by modified European Organization for Research and Treatment of Cancer Mycoses Study Group \[EORTC/MSC\] criteria) or microbiologically confirmed scedosporium or fusarium infection. | percentage of participants | NUMBER |
| SECONDARY | All-Cause Mortality - Number of Participant Deaths | Week 6 and EOT (up to Week 12) | Safety population | participants | NUMBER |
| SECONDARY | Attributable Mortality - Number of Participant Deaths | Weeks 6 and EOT (up to Week 12) | Safety population | participants | NUMBER |
| SECONDARY | Time to Death | Baseline up to 1 month post treatment | Safety population; only participants who died were included in the analysis. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | Voriconazole: 2 to <12 Years | With AEs | 11 | participants | |
| Number of Participants With Adverse Events (AEs) | Voriconazole: 12 to <18 Years | With AEs | 19 | participants | |
| Number of Participants With Adverse Events (AEs) | Voriconazole: 2 to <12 Years | With serious AEs | 6 | participants | |
| Number of Participants With Adverse Events (AEs) | Voriconazole: 12 to <18 Years | With serious AEs | 9 | participants | |
| Number of Participants With Adverse Events (AEs) | Voriconazole: 2 to <12 Years | With severe AEs | 5 | participants | |
| Number of Participants With Adverse Events (AEs) | Voriconazole: 12 to <18 Years | With severe AEs | 8 | participants | |
| Number of Participants With Adverse Events (AEs) | Voriconazole: 2 to <12 Years | Discontinued treatment due to AEs | 1 | participants | |
| Number of Participants With Adverse Events (AEs) | Voriconazole: 12 to <18 Years | Discontinued treatment due to AEs | 0 | participants | |
| Number of Participants With Adverse Events (AEs) | Voriconazole: 2 to <12 Years | Dose reduced or temporarily discontinued due to AE | 0 | participants | |
| Number of Participants With Adverse Events (AEs) | Voriconazole: 12 to <18 Years | Dose reduced or temporarily discontinued due to AE | 4 | participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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 | 11 | |
| Overall Study | STARTED | Voriconazole: 12 to <18 Years | 20 | |
| Overall Study | COMPLETED | Voriconazole: 2 to <12 Years | 8 | |
| Overall Study | COMPLETED | Voriconazole: 12 to <18 Years | 17 | |
| Overall Study | NOT COMPLETED | Voriconazole: 2 to <12 Years | 3 | |
| Overall Study | NOT COMPLETED | Voriconazole: 12 to <18 Years | 3 |
Source ClinicalTrials.gov
Adverse events382
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 | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Voriconazole: 2 to <12 Years | 0 | 11 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Voriconazole: 12 to <18 Years | 1 | 20 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Voriconazole: 2 to <12 Years | 0 | 11 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Voriconazole: 12 to <18 Years | 2 | 20 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Voriconazole: 2 to <12 Years | 1 | 11 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Voriconazole: 12 to <18 Years | 0 | 20 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Voriconazole: 2 to <12 Years | 0 | 11 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Voriconazole: 12 to <18 Years | 1 | 20 | |
| other | Neutropenia | Blood and lymphatic system disorders | Voriconazole: 2 to <12 Years | 1 | 11 | |
| other | Neutropenia | Blood and lymphatic system disorders | Voriconazole: 12 to <18 Years | 0 | 20 |
1 to 10 of 382Source ClinicalTrials.gov
See all 382 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 | 10 | 11 |
| Total, other adverse events | Voriconazole: 12 to <18 Years | 19 | 20 |
| Total, serious adverse events | Voriconazole: 2 to <12 Years | 6 | 11 |
| Total, serious adverse events | Voriconazole: 12 to <18 Years | 9 | 20 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Voriconazole: 2 to <12 Years vs Voriconazole: 12 to <18 Years: Attributable Mortality - Number of Participant Deaths | Trial comparisons |
| Voriconazole: 2 to <12 Years vs Voriconazole: 12 to <18 Years: 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/NCT00836875
GET https://conductscience.org/api/trials/v1/NCT00836875/results?page=2