Serious Fungal InfectionsNCT01073618
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
An observational study of Serious Fungal Infections, run by Pfizer.
Trial summary
This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Serious Fungal Infections
- What is being tested?
- voriconazole IV
- Type of treatment
- Injection or infusion
- How many people
- 692 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Oct 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are indicated for VFEND according to drug package insert.
Who may be able to join
- Invasive aspergillosis and other serious fungal infections.
Who cannot join
- N/A
About this study
Official title: Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.
- Conditions
- Serious Fungal Infections
- Being tested
- voriconazole IV
- Keywords
- voriconazole, Korea, invasive fungal infection
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voriconazole IVDrug
Also called Vfend
6 mg/kg iv q 12 hours (loading) then maintenance
| Study group | Role | What they receive |
|---|---|---|
| A. | Patients who are indicated for VFEND according to drug package insert. Receives: Drug: voriconazole IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable
Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).
Measured: Baseline (Day 1) up to 2 years
Secondary outcomes (1)
Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable
In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study medication; Not evaluable=a follow-up mycological cultivation is not performed.
Measured: Baseline (Day 1) up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startMar 2006
- 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 Serious Fungal InfectionsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073618
- Sponsor's protocol ID
- A1501067
- Status last verified
- May 2012
- First submitted
- 22 Feb 2010
- Last updated
- 7 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
- ClinicalTrials.gov ID
- NCT01073618
- Acronym / sponsor ID
- A1501067
- Conditions
- Serious Fungal Infections
- Keywords
- voriconazole, Korea, invasive fungal infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Posted 16 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A. | – | Drug: voriconazole IVPatients who are indicated for VFEND according to drug package insert. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are indicated for VFEND according to drug package insert.
Key inclusion criteria (1 listed)
- Invasive aspergillosis and other serious fungal infections.
Key exclusion criteria (1 listed)
- N/A
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 IVAlso: Vfend6 mg/kg iv q 12 hours (loading) then maintenance | Drug | A. |
Primary outcome
Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable
Time frame: Baseline (Day 1) up to 2 years
Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).
1 secondary outcome
Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable
Time frame: Baseline (Day 1) up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Serious Fungal Infections, run by Pfizer.
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 1 inclusion and 1 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2010). 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?
Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable (time frame: Baseline (Day 1) up to 2 years). 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 7 Jun 2012.