Trial · NCT01383993
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection
NCT01383993, Phase 2, Completed, Pfizer; results first posted 2014-05-09
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 Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection. Trials, record NCT01383993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01383993
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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 Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection
- NCT number
- NCT01383993
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Aspergillosis, Aspergilloma
- Interventions
- Voriconazole, Voriconazole
- First posted
- 2011-06-28
- Last updated
- 2014-05-09
- Results first posted
- 2014-05-09
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 Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration | Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion | AUC12,ss was obtained by the Linear/Log trapezoidal method. |
| Primary | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration | Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion | |
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration | Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion | |
| Primary | Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration | Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing | AUC12,ss was obtained by the Linear/Log trapezoidal method. |
| Primary | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration | Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing | |
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration | Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing | |
| Primary | Number of Participants Assessed Near Distance Visual Acuity Test | Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit | |
| Primary | Number of Participants Assessed Color Vision Test | Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit | |
| Primary | Number of Participants Assessed Visual Questionnaire | Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit | |
| Secondary | Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration | AUC12, ss for IV:Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion. AUC12,ss for oral: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing. | Ratio was calculated from the following formula; AUC12,ss Following Oral Administration over AUC12,ss Following IV Administration |
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 Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration | Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion | The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest. | μg*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration | Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion | The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest. | mcg/mL | GEOMETRIC_MEAN |
| PRIMARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration | Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion | The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest. | hrs | MEDIAN |
| PRIMARY | Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration | Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing | The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest. | μg*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration | Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing | The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest. | mcg/mL | GEOMETRIC_MEAN |
| PRIMARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration | Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing | The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest. | hrs | MEDIAN |
| PRIMARY | Number of Participants Assessed Near Distance Visual Acuity Test | Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit | The safety analysis was performed on all subjects who received at least 1 dose of study medication. | participants | NUMBER |
| PRIMARY | Number of Participants Assessed Color Vision Test | Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit | The safety analysis was performed on all subjects who received at least 1 dose of study medication. | participants | NUMBER |
| PRIMARY | Number of Participants Assessed Visual Questionnaire | Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit | The safety analysis was performed on all subjects who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration | AUC12, ss for IV:Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion. AUC12,ss for oral: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing. | The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest. | ratio | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration | Participants Aged 2 to <12 Years | 51.92 | Geometric Coefficient of Variation 51 | μg*h/mL | |
| Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration | Participants Aged 12 to<15 Years and Weighed <50 kg | 83.39 | Geometric Coefficient of Variation 56 | μg*h/mL | |
| Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration | Participants Aged 12 to<15 Years and Weighed ≥50 kg | 17.27 | Geometric Coefficient of Variation 28 | μg*h/mL | |
| Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration | Participants Aged 2 to <12 Years | 7.753 | Geometric Coefficient of Variation 38 | mcg/mL | |
| Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration | Participants Aged 12 to<15 Years and Weighed <50 kg | 9.233 | Geometric Coefficient of Variation 55 | mcg/mL | |
| Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration | Participants Aged 12 to<15 Years and Weighed ≥50 kg | 3.092 | Geometric Coefficient of Variation 42 | mcg/mL | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration | Participants Aged 2 to <12 Years | 2.96 | Full Range 0.950 to 4.00 | hrs | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration | Participants Aged 12 to<15 Years and Weighed <50 kg | 4.00 | Full Range 2.92 to 4.20 | hrs | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration | Participants Aged 12 to<15 Years and Weighed ≥50 kg | 1.34 | Full Range 1.00 to 1.67 | hrs | |
| Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration | Participants Aged 2 to <12 Years | 48.23 | Geometric Coefficient of Variation 83 | μg*h/mL |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants Aged 2 to <12 Years | 15 | |
| Overall Study | STARTED | Participants Aged 12 to<15 Years and Weighed <50 kg | 4 | |
| Overall Study | STARTED | Participants Aged 12 to<15 Years and Weighed ≥50 kg | 2 | |
| Overall Study | COMPLETED | Participants Aged 2 to <12 Years | 12 | |
| Overall Study | COMPLETED | Participants Aged 12 to<15 Years and Weighed <50 kg | 3 | |
| Overall Study | COMPLETED | Participants Aged 12 to<15 Years and Weighed ≥50 kg | 1 | |
| Overall Study | NOT COMPLETED | Participants Aged 2 to <12 Years | 3 | |
| Overall Study | NOT COMPLETED | Participants Aged 12 to<15 Years and Weighed <50 kg | 1 | |
| Overall Study | NOT COMPLETED | Participants Aged 12 to<15 Years and Weighed ≥50 kg | 1 |
Source ClinicalTrials.gov
Adverse events138
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 | Febrile neutropenia | Blood and lymphatic system disorders | Participants Aged 2 to <12 Years | 10 | 15 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Participants Aged 12 to<15 Years and Weighed <50 kg | 2 | 4 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Participants Aged 12 to<15 Years and Weighed ≥50 kg | 1 | 2 | |
| other | Histiocytosis haematophagic | Blood and lymphatic system disorders | Participants Aged 2 to <12 Years | 1 | 15 | |
| other | Histiocytosis haematophagic | Blood and lymphatic system disorders | Participants Aged 12 to<15 Years and Weighed <50 kg | 0 | 4 | |
| other | Histiocytosis haematophagic | Blood and lymphatic system disorders | Participants Aged 12 to<15 Years and Weighed ≥50 kg | 0 | 2 | |
| other | Colour blindness | Congenital, familial and genetic disorders | Participants Aged 2 to <12 Years | 1 | 15 | |
| other | Colour blindness | Congenital, familial and genetic disorders | Participants Aged 12 to<15 Years and Weighed <50 kg | 0 | 4 | |
| other | Colour blindness | Congenital, familial and genetic disorders | Participants Aged 12 to<15 Years and Weighed ≥50 kg | 0 | 2 | |
| other | Chromatopsia | Eye disorders | Participants Aged 2 to <12 Years | 0 | 15 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants Aged 2 to <12 Years | ||
| Total, all-cause mortality | Participants Aged 12 to<15 Years and Weighed <50 kg | ||
| Total, all-cause mortality | Participants Aged 12 to<15 Years and Weighed ≥50 kg | ||
| Total, other adverse events | Participants Aged 2 to <12 Years | 13 | 15 |
| Total, other adverse events | Participants Aged 12 to<15 Years and Weighed <50 kg | 4 | 4 |
| Total, other adverse events | Participants Aged 12 to<15 Years and Weighed ≥50 kg | 1 | 2 |
| Total, serious adverse events | Participants Aged 2 to <12 Years | 0 | 15 |
| Total, serious adverse events | Participants Aged 12 to<15 Years and Weighed <50 kg | 0 | 4 |
| Total, serious adverse events | Participants Aged 12 to<15 Years and Weighed ≥50 kg | 0 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25451051 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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