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CompletedNCT00143312VOSIFIUpdated Oct 6, 2009Results posted

Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants

A Phase 4 interventional study of voriconazole in Prophylaxis Of Invasive Fungal Infections, sponsored by Pfizer. Completed at 17 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-06.

Sponsored by Pfizer · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

02

Conditions studied

  • Prophylaxis Of Invasive Fungal Infections

Keywords

  • Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 45 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with proven or probable IFI in previous 12 months receiving an allogenic stem cell transplant for any haematological disease

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    1

    Drug: voriconazole

Interventions

  • Drugvoriconazole

    Voriconazole is given to patients at least 48 hours after chemotherapy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 150 days

  3. 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.

    Time frame: 12 months

  4. 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.

    Time frame: 12 months

  5. 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.

    Time frame: 12 months

  6. 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

    Time frame: 6 months, 12 months

07

Results

Posted Jun 1, 2009

Participant flow

Participant flow — Overall Study
MilestoneVoriconazole
Started45
Completed29
Not completed16
Withdrew: Death11
Withdrew: Adverse event2
Withdrew: Lost to follow-up1
Withdrew: Other1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryOccurrence 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

Time frame:
12 months
Reported as:
Number · participants
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit
participantsVoriconazole
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit3
Statistical analysis
  • Voriconazole · Crude ifi rate (percent) at 12 months: 7 · 95% CI 2 to 19
  • Voriconazole · Ifi rate (percent) at 12 months: 10 · 95% CI 2 to 27
SecondaryOccurrence 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

Time frame:
6 months
Reported as:
Number · participants
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit
participantsVoriconazole
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit3
Statistical analysis
  • Voriconazole · Ifi rate (percent) at 6 months: 8.82 · 95% CI 2 to 24Exact 95% Confidence Interval For Proportion; Expressed as a percentage
SecondaryOccurrence 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

Time frame:
150 days
Reported as:
Number · participants
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit
participantsVoriconazole
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit3
Statistical analysis
  • Voriconazole · Ifi rate (percent) at end of prophylaxis: 8.82 · 95% CI 2 to 24Exact 95% Confidence Interval For Proportion; Expressed as a percentage
SecondaryTime 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.

Time frame:
12 months
Reported as:
Number · days
Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)
daysVoriconazole
time to recurrent IFI (first subject)6
time to recurrent IFI (second subject)22
time to recurrent IFI (third subject)81
SecondaryTime 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.

Time frame:
12 months
Reported as:
Number · days
Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)
daysVoriconazole
Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)81
SecondaryTime 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.

Time frame:
12 months
Reported as:
Number · days
Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)
daysVoriconazole
time to IFI (first subject)6
time to IFI (second subject)22
SecondarySurvival 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

Time frame:
6 months, 12 months
Reported as:
Number · participants
Survival Without Proven or Probable Invasive Fungal Infection (IFI)
participantsVoriconazole
survived free of IFI until 6 months31
survived free of IFI until 12 months27
Statistical analysis
  • Voriconazole · Survive free of ifi (percent): 6 months: 79 · 95% CI 64 to 91Exact 95% Confidence Interval For Proportion; Expressed as a percentage
  • Voriconazole · Survive free of ifi (percent): 12 months: 69 · 95% CI 52 to 83Exact 95% Confidence Interval For Proportion; Expressed as a percentage

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Voriconazole—23/45 (51.1%)42/45 (93.3%)
Most frequent serious events
Showing 10 of 45
Most frequent serious events
EventVoriconazole
VomitingGastrointestinal disorders3/45
DiarrhoeaGastrointestinal disorders2/45
Graft versus host diseaseImmune system disorders2/45
HepatotoxicityHepatobiliary disorders2/45
PyrexiaGeneral disorders2/45
SepsisInfections and infestations2/45
Abdominal painGastrointestinal disorders1/45
Acute myeloid leukaemia recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/45
Atrial fibrillationCardiac disorders1/45
Blood creatine increasedInvestigations1/45
Most frequent other events
Showing 10 of 41
Most frequent other events
EventVoriconazole
Mucosal inflammationGeneral disorders17/45
DiarrhoeaGastrointestinal disorders15/45
HeadacheNervous system disorders13/45
PyrexiaGeneral disorders13/45
VomitingGastrointestinal disorders13/45
Graft versus host diseaseImmune system disorders12/45
Febrile neutropeniaBlood and lymphatic system disorders8/45
HypertensionVascular disorders8/45
Abdominal painGastrointestinal disorders7/45
AnaemiaBlood and lymphatic system disorders7/45

Baseline characteristics

Age Continuous
Age Continuous(years)Voriconazole
Mean48.4 ± 14.1
Sex: Female, Male
Sex: Female, Male(Participants)Voriconazole
Female17
Male28
08

Study locations

17 sites
  • Pfizer Investigational Site
    Leuven, 3000, Belgium
  • Pfizer Investigational Site
    Marseille, Cedex 09 13273, France
  • Pfizer Investigational Site
    Creteil, 94010, France
  • Pfizer Investigational Site
    Nantes, 44035 cedex, France
  • Pfizer Investigational Site
    Pessac, 33600, France
  • Pfizer Investigational Site
    Strasbourg, 67098, France
  • Pfizer Investigational Site
    Koeln, 50937, Germany
  • Pfizer Investigational Site
    Mainz, 55101, Germany
  • Pfizer Investigational Site
    Wuerzburg, 97070, Germany
  • Pfizer Investigational Site
    Lisboa, 1099-023, Portugal
  • Pfizer Investigational Site
    Barcelona, 08025, Spain
  • Pfizer Investigational Site
    Barcelona, 08036, Spain
  • Pfizer Investigational Site
    Madrid, 28006, Spain
  • Pfizer Investigational Site
    Stockholm, 141 86, Sweden
  • Pfizer Investigational Site
    CH-4031 Basel, Switzerland
  • Pfizer Investigational Site
    London, W12 0NN, United Kingdom
  • Pfizer Investigational Site
    Manchester, M20 4BX, United Kingdom
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00143312
Lead sponsor
Pfizer
Collaborators
European Society for Blood and Marrow Transplantation
First posted
Sep 2, 2005
Start date
Feb 2005
Primary completion
Apr 2008
Completion
Apr 2008
Results posted
Jun 1, 2009
Last update
Oct 6, 2009

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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