CandidiasisPhase 2NCT00739934
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
A Phase 2 study testing voriconazole (Vfend) in people with Candidiasis and Candidemia, run by Pfizer at 14 sites in United States.
Trial summary
In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Candidiasis, Candidemia
- What is being tested?
- voriconazole (Vfend)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 14 sitesUnited States
- Study dates
- Dec 2008to Oct 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female from 2 to <12 years of age.
- Require treatment for the prevention of systemic fungal infection.
- Expected to develop neutropenia (ANC <500 cells/μL) lasting more than 10 days following chemotherapy.
- Anticipated to live for more than 3 months.
Who cannot join
- Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.
- Documented bacterial or viral infection not responding to appropriate treatment.
- Hypersensitivity to or severe intolerance of azole antifungal agents.
- Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Pfizer Investigational Site
Atlanta, Georgia, 30322-1062
Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Atlanta, Georgia, 30342-1600
Pfizer Investigational Site
Baltimore, Maryland, 21215
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Jacksonville, Florida, 32207
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
New Orleans, Louisiana, 70118
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Tucson, Arizona, 85719
Pfizer Investigational Site
Tucson, Arizona, 85724
About this study
Official title: An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To <12 Years Who Are At High Risk For Systemic Fungal Infection
In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.
- Conditions
- Candidiasis, Candidemia
- Being tested
- voriconazole (Vfend)
- Keywords
- Open-Label, Pharmacokinetics, Intravenous to oral switch, Safety, Voriconazole, Immunocompromise, Children, High Risk For Systemic Fungal Infection.
- Medical subject headings
- Candidiasis, Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voriconazole (Vfend)Drug
Also called UK-109,496; Vfend; voriconazole
Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h
Notes:
- If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
- Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30. (IV = Intravenous; POS = Powder for oral suspension)
| Study group | Role | What they receive |
|---|---|---|
| Children aged 2 to <12 years | Experimental | Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Receives: Drug: voriconazole (Vfend) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration
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.
Measured: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
Measured: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Time to Reach Cmax (Tmax) Following IV Administration
Measured: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
AUC12,ss Following Oral Administration
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.
Measured: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Cmax,ss Following Oral Administration
Measured: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Tmax Following Oral Administration
Measured: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Secondary outcomes (10)
AUC12 Following IV Loading Dose
AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.
Measured: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Cmax Following an IV Loading Dose
Measured: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Tmax Following an IV Loading Dose
Measured: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Trough Concentrations (Cmin)
Measured: Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
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.
Measured: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Measured: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process.
Measured: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
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.
Measured: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Measured: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Measured: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CandidiasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739934
- Sponsor's protocol ID
- A1501088
- Status last verified
- Jan 2011
- First submitted
- 20 Aug 2008
- Last updated
- 28 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To <12 Years Who Are At High Risk For Systemic Fungal Infection
- ClinicalTrials.gov ID
- NCT00739934
- Acronym / sponsor ID
- A1501088
- Conditions
- Candidiasis, Candidemia
- Keywords
- Open-Label, Pharmacokinetics, Intravenous to oral switch, Safety, Voriconazole, Immunocompromise, Children, High Risk For Systemic Fungal Infection.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Posted 25 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children aged 2 to <12 years | Experimental | Drug: voriconazole (Vfend)Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female from 2 to <12 years of age.
- Require treatment for the prevention of systemic fungal infection.
- Expected to develop neutropenia (ANC <500 cells/μL) lasting more than 10 days following chemotherapy.
- Anticipated to live for more than 3 months.
Key exclusion criteria (4 listed)
- Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.
- Documented bacterial or viral infection not responding to appropriate treatment.
- Hypersensitivity to or severe intolerance of azole antifungal agents.
- Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| voriconazole (Vfend)Also: UK-109,496; Vfend; voriconazoleStudy Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h Notes: 1. If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose. 2. Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30. (IV = Intravenous; POS = Powder for oral suspension) | Drug | Children aged 2 to <12 years |
Primary outcome
Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration
Time frame: 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.
Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
Time frame: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Time to Reach Cmax (Tmax) Following IV Administration
Time frame: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
AUC12,ss Following Oral Administration
Time frame: 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.
Cmax,ss Following Oral Administration
Time frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Tmax Following Oral Administration
Time frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
10 secondary outcomes
AUC12 Following IV Loading Dose
Time frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Cmax Following an IV Loading Dose
Time frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Tmax Following an IV Loading Dose
Time frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Trough Concentrations (Cmin)
Time frame: Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Time frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Time frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Time frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Time frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Time frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Time frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing voriconazole (Vfend) in people with Candidiasis and Candidemia, run by Pfizer at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration (time frame: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2011; AzTrials last refreshed its copy on 8 Nov 2026.