Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT) - Clinical Trial for Antifungal Prophylaxis of Invasive Fungal Infections | NCT00289991

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Itraconazole

Vfend - voriconazole

About this trial

This is an interventional prevention trial for Antifungal Prophylaxis of Invasive Fungal Infections

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Itraconazole

Voriconazole

Arm Description

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

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

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)

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

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

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 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

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

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

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.

Full Information

NCT ID

NCT00289991

First Posted

February 9, 2006

Last Updated

October 16, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00289991

Brief Title

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

Acronym

IMPROVIT

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Antifungal Prophylaxis of Invasive Fungal Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

489 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Itraconazole

Arm Type

Active Comparator

Arm Title

Voriconazole

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Itraconazole

Intervention Description

Prophylaxis

Intervention Type

Drug

Intervention Name(s)

Vfend - voriconazole

Other Intervention Name(s)

Vfend

Intervention Description

Prophylaxis

Primary Outcome Measure Information:

Title

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

Description

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).

Time Frame

Day 180 (Visit 9)

Secondary Outcome Measure Information:

Title

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

Description

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 Frame

Day 100 (Visit 7)

Title

Time to Breakthrough Invasive Fungal Infection (IFI)

Description

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

Time Frame

Day 1 up to Day 180 (Visit 9)

Title

Percent of Subjects With Occurrence of Breakthrough IFI

Description

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

Time Frame

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

Title

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

Description

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 Frame

Day 1 up to Day 180 (Visit 9)

Title

Time to Discontinuation of Study Treatment

Description

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.

Time Frame

Day 1 up to Day 180 (Visit 9)

Title

Survival: Percent of Subjects Who Died Within 1 Year

Description

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.

Time Frame

Day 1 up to 1 year (Day 365)

Title

Duration of Treatment

Description

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

Time Frame

Day 1 up to Day 180

Title

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

Description

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.

Time Frame

Day 1 up to Day 180

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Bmo

ZIP/Postal Code

625 00

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Praha

ZIP/Postal Code

128 20

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Cairo

Country

Egypt

Facility Name

Pfizer Investigational Site

City

Marseille

State/Province

Cedex 09

ZIP/Postal Code

13273

Country

France

Facility Name

Pfizer Investigational Site

City

Caen

ZIP/Postal Code

14033

Country

France

Facility Name

Pfizer Investigational Site

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

Pfizer Investigational Site

City

Pessac

ZIP/Postal Code

33600

Country

France

Facility Name

Pfizer Investigational Site

City

Rouen Cedex

ZIP/Postal Code

76038

Country

France

Facility Name

Pfizer Investigational Site

City

Vandoeuvre Les Nancy Cedex

ZIP/Postal Code

54511

Country

France

Facility Name

Pfizer Investigational Site

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Pfizer Investigational Site

City

Exohi Asvestohoriou

State/Province

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Pfizer Investigational Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Pfizer Investigational Site

City

Amman

Country

Jordan

Facility Name

Pfizer Investigational Site

City

Lisboa

ZIP/Postal Code

1099-023

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St. Petersburg

ZIP/Postal Code

197089

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Pfizer Investigational Site

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Pfizer Investigational Site

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Pfizer Investigational Site

City

CH-4031 Basel

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Geneve

ZIP/Postal Code

CH-1211

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Bristol

ZIP/Postal Code

BS2 8BL

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Cambridge

ZIP/Postal Code

CB2 2QQ

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Cardiff

ZIP/Postal Code

CF14 4XW

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Glasgow

ZIP/Postal Code

G4 0SF

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Leeds

ZIP/Postal Code

LS9-7TF

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Leicester

ZIP/Postal Code

LW1 5WW

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

Nw3 2qg

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501073

Description

To obtain contact information for a study center near you, click here.

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

Antifungal Prophylaxis of Invasive Fungal Infections

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial