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Trial record 18 of 799 for:    Clotrimazole AND Fungal Infections

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

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ClinicalTrials.gov Identifier: NCT00289991
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : March 10, 2010
Last Update Posted : November 20, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE February 9, 2006
First Posted Date  ICMJE February 10, 2006
Results First Submitted Date  ICMJE February 9, 2010
Results First Posted Date  ICMJE March 10, 2010
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE March 2006
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2010)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2006)
  • Survival at day 150
  • No breakthrough invasive fungal infection
  • No discontinuation of study medication for greater than 5 days
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2010)
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2006)
  • Success at day 100
  • Time to breakthrough IFI
  • Survival at day 150
  • Safety and Tolerability of two treatments
  • Durations of study treatments
  • Use of other systemic antifungal agents
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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