Prophylaxis Of Invasive Fungal InfectionsPhase 4VOSIFINCT00143312
Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
A Phase 4 study testing voriconazole in people with Prophylaxis Of Invasive Fungal Infections, run by Pfizer at 17 sites in 8 countries.
Trial summary
To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prophylaxis Of Invasive Fungal Infections
- What is being tested?
- voriconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 17 sitesin 8 countries
- Study dates
- Feb 2005to Apr 2008
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with proven or probable IFI in previous 12 months receiving an allogenic stem cell transplant for any haematological disease
Who cannot join
- Pregnant or lactating women
- Severe disease other tham the underlying condition
- Active, symptomatic uncontrolled Invasive Fungal Infection
- Any evidence of active fungal disease as defined by MSG-EORTC criteria
- Concomitant use of Voriconazole 36 hours before chemotherapy until 48 hours after chemotherapy
- Other medical conditions, including HIV positive serology that would interfere with the evaluation of therapeutic response or safety of study drug
Trial locations and contacts
17 sites in 8 countries.
17 sites in 8 countries
France5 sites
Pfizer Investigational Site
Créteil, 94010
Pfizer Investigational Site
Marseille, Cedex 09, 13273
Pfizer Investigational Site
Nantes, 44035 cedex
Pfizer Investigational Site
Pessac, 33600
Pfizer Investigational Site
Strasbourg, 67098
Germany3 sites
Pfizer Investigational Site
Cologne, 50937
Pfizer Investigational Site
Mainz, 55101
Pfizer Investigational Site
Würzburg, 97070
Spain3 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08025
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Madrid, Madrid, 28006
United Kingdom2 sites
Pfizer Investigational Site
London, W12 0NN
Pfizer Investigational Site
Manchester, M20 4BX
About this study
Official title: Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT).
To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants
- Being tested
- voriconazole
- Keywords
- Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole
- Medical subject headings
- Invasive Fungal Infections, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voriconazoleDrug
Voriconazole is given to patients at least 48 hours after chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up
Measured: 12 months
Secondary outcomes (6)
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up
Measured: 6 months
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit
Measured: 150 days
Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)
Time to occurrence of proven or probable IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI since the exact day on which the IFI began will not be known.
Measured: 12 months
Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)
Time to occurrence of proven or probable new (new pathogen) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI.
Measured: 12 months
Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)
Time to occurrence of proven or probable recurrent (same pathogen as baseline) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. The pathogen identified as the positive culture recorded nearest to, but not after, the proven or probable IFI, was assumed to be responsible for the IFI.
Measured: 12 months
Survival Without Proven or Probable Invasive Fungal Infection (IFI)
Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionApr 2008
- Study completionApr 2008
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 Prophylaxis Of Invasive 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Society for Blood and Marrow Transplantation
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143312
- Sponsor's protocol ID
- A1501038
- Acronym
- VOSIFI
- Status last verified
- Sep 2009
- First submitted
- 31 Aug 2005
- Last updated
- 6 Oct 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT).
- ClinicalTrials.gov ID
- NCT00143312
- Acronym / sponsor ID
- VOSIFI / A1501038
- Keywords
- Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- European Society for Blood and Marrow Transplantation
- Study start
- Feb 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Posted 1 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: voriconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with proven or probable IFI in previous 12 months receiving an allogenic stem cell transplant for any haematological disease
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Severe disease other tham the underlying condition
- Active, symptomatic uncontrolled Invasive Fungal Infection
- Any evidence of active fungal disease as defined by MSG-EORTC criteria
- Concomitant use of Voriconazole 36 hours before chemotherapy until 48 hours after chemotherapy
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 |
|---|---|---|
| voriconazoleVoriconazole is given to patients at least 48 hours after chemotherapy | Drug | 1 |
Primary outcome
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit
Time frame: 12 months
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up
6 secondary outcomes
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit
Time frame: 6 months
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit
Time frame: 150 days
Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)
Time frame: 12 months
Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)
Time frame: 12 months
Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)
Time frame: 12 months
Survival Without Proven or Probable Invasive Fungal Infection (IFI)
Time frame: 6 months, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
- 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
17 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing voriconazole in people with Prophylaxis Of Invasive Fungal Infections, run by Pfizer at 17 sites in 8 countries.
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 6 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 6 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Germany, Spain, United Kingdom, Belgium and 3 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 1 Jun 2009). 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?
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit (time frame: 12 months). 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 6 Oct 2009.