Trial · NCT00739934
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
NCT00739934, Phase 2, Completed, Pfizer; results first posted 2011-01-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection. Trials, record NCT00739934. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00739934
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
- NCT number
- NCT00739934
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Candidiasis, Candidemia
- Interventions
- voriconazole (Vfend)
- First posted
- 2008-08-22
- Last updated
- 2011-01-28
- Results first posted
- 2011-01-25
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration | Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method. |
| Primary | Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration | Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | |
| Primary | Time to Reach Cmax (Tmax) Following IV Administration | Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | |
| Primary | AUC12,ss Following Oral Administration | Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose | AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method. |
| Primary | Cmax,ss Following Oral Administration | Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose | |
| Primary | Tmax Following Oral Administration | Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose | |
| Secondary | AUC12 Following IV Loading Dose | Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method. |
| Secondary | Cmax Following an IV Loading Dose | Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | |
| Secondary | Tmax Following an IV Loading Dose | Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | |
| Secondary | Trough Concentrations (Cmin) | Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration | Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | Intent-to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data. | μg*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration | Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | μg/mL | GEOMETRIC_MEAN |
| PRIMARY | Time to Reach Cmax (Tmax) Following IV Administration | Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | hours | MEDIAN |
| PRIMARY | AUC12,ss Following Oral Administration | Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | μg*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Cmax,ss Following Oral Administration | Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | μg/mL | GEOMETRIC_MEAN |
| PRIMARY | Tmax Following Oral Administration | Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | hours | MEDIAN |
| SECONDARY | AUC12 Following IV Loading Dose | Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | μg*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax Following an IV Loading Dose | Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Tmax Following an IV Loading Dose | Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data. | hours | MEDIAN |
| SECONDARY | Trough Concentrations (Cmin) | Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose | ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data. | μg/mL | GEOMETRIC_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration | Voriconazole IV | 21.42 | Standard Deviation 35.05 | μg*h/mL | |
| Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration | Voriconazole IV | 4.26 | Standard Deviation 3.73 | μg/mL | |
| Time to Reach Cmax (Tmax) Following IV Administration | Voriconazole IV | 2.30 | Full Range 1.00 to 4.07 | hours | |
| AUC12,ss Following Oral Administration | Voriconazole Oral | 18.64 | Standard Deviation 50.63 | μg*h/mL | |
| Cmax,ss Following Oral Administration | Voriconazole Oral | 3.62 | Standard Deviation 4.66 | μg/mL | |
| Tmax Following Oral Administration | Voriconazole Oral | 1.07 | Full Range 0.73 to 8.03 | hours | |
| AUC12 Following IV Loading Dose | Voriconazole IV | 7.85 | Standard Deviation 6.71 | μg*h/mL | |
| Cmax Following an IV Loading Dose | Voriconazole IV | 2.15 | Standard Deviation 1.10 | μg/mL | |
| Tmax Following an IV Loading Dose | Voriconazole IV | 2.30 | Full Range 1.72 to 4.08 | hours | |
| Trough Concentrations (Cmin) | All Treatments | IV Day 7 (up to Day 20) (n=36) | 0.61 | Standard Deviation 2.56 | μg/mL |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Voriconazole IV | STARTED | All Participants | 40 | |
| Voriconazole IV | COMPLETED | All Participants | 34 | |
| Voriconazole IV | NOT COMPLETED | All Participants | 6 | |
| Voriconazole Oral | STARTED | All Participants | 34 | |
| Voriconazole Oral | COMPLETED | All Participants | 31 | |
| Voriconazole Oral | NOT COMPLETED | All Participants | 3 |
Source ClinicalTrials.gov
Adverse events522
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 IV | 1 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Voriconazole Oral | 1 | 34 | |
| other | Haemolysis | Blood and lymphatic system disorders | Voriconazole IV | 1 | 40 | |
| other | Haemolysis | Blood and lymphatic system disorders | Voriconazole Oral | 1 | 34 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Voriconazole IV | 1 | 40 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Voriconazole Oral | 0 | 34 | |
| other | Neutropenia | Blood and lymphatic system disorders | Voriconazole IV | 3 | 40 | |
| other | Neutropenia | Blood and lymphatic system disorders | Voriconazole Oral | 1 | 34 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Voriconazole IV | 2 | 40 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Voriconazole Oral | 1 | 34 |
1 to 10 of 522Source ClinicalTrials.gov
See all 522 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Voriconazole IV | ||
| Total, all-cause mortality | Voriconazole Oral | ||
| Total, other adverse events | Voriconazole IV | 39 | 40 |
| Total, other adverse events | Voriconazole Oral | 34 | 34 |
| Total, serious adverse events | Voriconazole IV | 6 | 40 |
| Total, serious adverse events | Voriconazole Oral | 13 | 34 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 IV vs Voriconazole Oral: 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/NCT00739934
GET https://conductscience.org/api/trials/v1/NCT00739934/events?page=2