Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
NCT00289991
Last updated date
ABOUT THIS STUDY
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 Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
- Vancouver, British Columbia
- Winnipeg, Manitoba
- Winnipeg, Manitoba
- Hamilton, Ontario
- Montreal, Quebec
- Bmo,
- Praha,
- Cairo,
- Marseille, Cedex 09
- Caen,
- Creteil,
- Paris,
- Pessac,
- Rouen Cedex,
- Vandoeuvre Les Nancy Cedex,
- Villejuif,
- Exohi Asvestohoriou, Thessaloniki
- Athens,
- Amman,
- Lisboa,
- Porto,
- Moscow,
- St. Petersburg,
- Badalona, Barcelona
- Barcelona,
- Barcelona,
- Madrid,
- Madrid,
- Madrid,
- Salamanca,
- Sevilla,
- Valencia,
- Valencia,
- CH-4031 Basel,
- Geneve,
- Ankara,
- Kayseri,
- Sutton, Surrey
- Bristol,
- Cambridge,
- Cardiff,
- Glasgow,
- Glasgow,
- Leeds,
- Leicester,
- London,
- London,
- London,
- 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 |
| |||
| Study Arms ICMJE |
| |||
| 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 | 489 | |||
| Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||