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Completed

NCT Number: NCT00289991

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

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.

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Key information

Conditions

Antifungal Prophylaxis of Invasive Fungal Infections

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Itraconazole

Drug

Prophylaxis

Vfend - voriconazole

Drug

Prophylaxis

Other names: Vfend

Primary outcomes

  1. Success at Day 180: Percent of Responders (Randomization Strata)

    Time frame: Day 180 (Visit 9)

    Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).

Secondary outcomes

  1. Success at Day 100: Percent of Responders (Randomization Strata)

    Time frame: Day 100 (Visit 7)

    Percent of responders (by randomization strata) with success of antifungal prophylaxis at 100 days after allogeneic HSCT. Success defined as: alive at Day 100 (Visit 7), had not developed a breakthrough proven or probable IFI by Visit 7, and received full course of study drug prophylaxis without an interruption of >14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 7, imputed as failure at Visit 7 (programmatically).

  2. Time to Breakthrough Invasive Fungal Infection (IFI)

    Time frame: Day 1 up to Day 180 (Visit 9)

    Summary of time (in days) from start of prophylaxis to first recorded occurrence of breakthrough proven or probable IFI.

  3. Percent of Subjects With Occurrence of Breakthrough IFI

    Time frame: Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)

    Percent of subjects with occurrence of breakthrough IFI (proven or probable). Included all subjects in the MITT population.

  4. Survival: Percent of Subjects Who Died at or Before Day 180

    Time frame: Day 1 up to Day 180 (Visit 9)

    Percent of subjects who died at or before Day 180, derived from the crude death rate. All subjects in the MITT population included in this proportion.

  5. Time to Discontinuation of Study Treatment

    Time frame: Day 1 up to Day 180 (Visit 9)

    Time in days to discontinuation of study treatment defined as the number of days from first dose to last dose inclusive as recorded in the dosing log.

  6. Survival: Percent of Subjects Who Died Within 1 Year

    Time frame: Day 1 up to 1 year (Day 365)

    Percent of subjects who died within 1 year after transplant, derived from the crude death rate. All subjects in the MITT population included in this proportion. Only deaths up until and including 365 days after first dose of study medication included in the analysis.

  7. Duration of Treatment

    Time frame: Day 1 up to Day 180

    Median duration in days of treatment. Treatment is defined as the total number of days on which subjects took medication.

  8. Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment

    Time frame: Day 1 up to Day 180

    Percent of subjects who used other systemic antifungal agents as empirical or therapeutic treatment, defined as either empirical: subject took a systemic antifungal agent at any time after the day of first dose of medication and did not develop a breakthrough proven or probable IFI during the study or therapeutic: subject developed a breakthrough proven or probable IFI.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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)

Acronym: IMPROVIT

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 10, 2006
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.