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

October 16, 2015 updated by: Pfizer

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
489

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Pfizer Investigational Site
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Pfizer Investigational Site
  • Czech Republic
      • Bmo, Czech Republic, 625 00
        • Pfizer Investigational Site
      • Praha, Czech Republic, 128 20
        • Pfizer Investigational Site
  • Egypt
      • Cairo, Egypt
        • Pfizer Investigational Site
  • France
      • Caen, France, 14033
        • Pfizer Investigational Site
      • Creteil, France, 94010
        • Pfizer Investigational Site
      • Paris, France, 75475
        • Pfizer Investigational Site
      • Pessac, France, 33600
        • Pfizer Investigational Site
      • Rouen Cedex, France, 76038
        • Pfizer Investigational Site
      • Vandoeuvre Les Nancy Cedex, France, 54511
        • Pfizer Investigational Site
      • Villejuif, France, 94805
        • Pfizer Investigational Site
    • Cedex 09
      • Marseille, Cedex 09, France, 13273
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 11527
        • Pfizer Investigational Site
    • Thessaloniki
      • Exohi Asvestohoriou, Thessaloniki, Greece, 57010
        • Pfizer Investigational Site
  • Jordan
      • Amman, Jordan
        • Pfizer Investigational Site
  • Portugal
      • Lisboa, Portugal, 1099-023
        • Pfizer Investigational Site
      • Porto, Portugal, 4200-072
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 117997
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 197089
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Barcelona, Spain, 08025
        • Pfizer Investigational Site
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Madrid, Spain, 28006
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Salamanca, Spain, 37007
        • Pfizer Investigational Site
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
      • Valencia, Spain, 46009
        • Pfizer Investigational Site
      • Valencia, Spain, 46010
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Pfizer Investigational Site
  • Switzerland
      • CH-4031 Basel, Switzerland
        • Pfizer Investigational Site
      • Geneve, Switzerland, CH-1211
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06590
        • Pfizer Investigational Site
      • Kayseri, Turkey, 38039
        • Pfizer Investigational Site
  • United Kingdom
      • Bristol, United Kingdom, BS2 8BL
        • Pfizer Investigational Site
      • Cambridge, United Kingdom, CB2 2QQ
        • Pfizer Investigational Site
      • Cardiff, United Kingdom, CF14 4XW
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G12 0YN
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G4 0SF
        • Pfizer Investigational Site
      • Leeds, United Kingdom, LS9-7TF
        • Pfizer Investigational Site
      • Leicester, United Kingdom, LW1 5WW
        • Pfizer Investigational Site
      • London, United Kingdom, SE5 9RS
        • Pfizer Investigational Site
      • London, United Kingdom, SE1 9RT
        • Pfizer Investigational Site
      • London, United Kingdom, NW3 2QG
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M20 4BX
        • Pfizer Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Itraconazole
Drug: Itraconazole
Prophylaxis
Experimental: Voriconazole
Drug: Vfend - voriconazole
Prophylaxis
Other Names:
  • Vfend

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Day 180 (Visit 9)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Day 100 (Visit 7)
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.
Day 1 up to Day 180 (Visit 9)
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.
Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)
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.
Day 1 up to Day 180 (Visit 9)
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.
Day 1 up to Day 180 (Visit 9)
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.
Day 1 up to 1 year (Day 365)
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.
Day 1 up to Day 180
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.
Day 1 up to Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A1501073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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