Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)

NCT00289991

Last updated date
Study Location
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 1M9, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Antifungal Prophylaxis of Invasive Fungal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failed lymphoma therapy or transformation of CML

- Male and Female over 12 years or greater

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Possible, probable or proven IFI at study entry or at any time in 6 months prior to
study entry, defined according to the 'consensus criteria' (Ascioglu et al 2002)


- Previous history of zygomycosis


- Anticipated survival less than one month

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Antifungal Prophylaxis of Invasive Fungal InfectionsVoriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT) NCT00289991
  1. Vancouver, British Columbia
  2. Winnipeg, Manitoba
  3. Winnipeg, Manitoba
  4. Hamilton, Ontario
  5. Montreal, Quebec
  6. Bmo,
  7. Praha,
  8. Cairo,
  9. Marseille, Cedex 09
  10. Caen,
  11. Creteil,
  12. Paris,
  13. Pessac,
  14. Rouen Cedex,
  15. Vandoeuvre Les Nancy Cedex,
  16. Villejuif,
  17. Exohi Asvestohoriou, Thessaloniki
  18. Athens,
  19. Amman,
  20. Lisboa,
  21. Porto,
  22. Moscow,
  23. St. Petersburg,
  24. Badalona, Barcelona
  25. Barcelona,
  26. Barcelona,
  27. Madrid,
  28. Madrid,
  29. Madrid,
  30. Salamanca,
  31. Sevilla,
  32. Valencia,
  33. Valencia,
  34. CH-4031 Basel,
  35. Geneve,
  36. Ankara,
  37. Kayseri,
  38. Sutton, Surrey
  39. Bristol,
  40. Cambridge,
  41. Cardiff,
  42. Glasgow,
  43. Glasgow,
  44. Leeds,
  45. Leicester,
  46. London,
  47. London,
  48. London,
  49. Manchester,
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
Official Title  ICMJE Prospective, Open-Label, Comparative, Multi-Center Study Of Voriconazole Compared To Itraconazole For The Primary Prophylaxis Of Invasive Fungal Infection (IFI) With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
Brief Summary Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Antifungal Prophylaxis of Invasive Fungal Infections
Intervention  ICMJE
  • Drug: Itraconazole
    Prophylaxis
  • Drug: Vfend - voriconazole
    Prophylaxis
    Other Name: Vfend
Study Arms  ICMJE
  • Active Comparator: Itraconazole
    Intervention: Drug: Itraconazole
  • Experimental: Voriconazole
    Intervention: Drug: Vfend - voriconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2010)
489
Original Enrollment  ICMJE
 (submitted: February 9, 2006)
500
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failed lymphoma therapy or transformation of CML
  • Male and Female over 12 years or greater

Exclusion Criteria:

  • Possible, probable or proven IFI at study entry or at any time in 6 months prior to study entry, defined according to the 'consensus criteria' (Ascioglu et al 2002)
  • Previous history of zygomycosis
  • Anticipated survival less than one month
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czech Republic,   Egypt,   France,   Greece,   Jordan,   Portugal,   Russian Federation,   Spain,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries Israel
 
Administrative Information
NCT Number  ICMJE NCT00289991
Other Study ID Numbers  ICMJE A1501073
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP