Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
NCT00143312
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Patients with proven or probable IFI in previous 12 months receiving an allogenic stem cell transplant for any haematological disease
- Pregnant or lactating women
- Severe disease other tham the underlying condition
- Active, symptomatic uncontrolled Invasive Fungal Infection
- Any evidence of active fungal disease as defined by MSG-EORTC criteria
- Concomitant use of Voriconazole 36 hours before chemotherapy until 48 hours after
chemotherapy
- Other medical conditions, including HIV positive serology that would interfere with
the evaluation of therapeutic response or safety of study drug
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Leuven,
- Marseille, Cedex 09
- Creteil,
- Nantes,
- Pessac,
- Strasbourg,
- Koeln,
- Mainz,
- Wuerzburg,
- Lisboa,
- Barcelona,
- Barcelona,
- Madrid,
- Stockholm,
- CH-4031 Basel,
- London,
- Manchester,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants | |||
Official Title ICMJE | Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT). | |||
Brief Summary | To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE | Prophylaxis Of Invasive Fungal Infections | |||
Intervention ICMJE | Drug: voriconazole
Voriconazole is given to patients at least 48 hours after chemotherapy | |||
Study Arms ICMJE | Experimental: 1
Intervention: Drug: 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 | 45 | |||
Original Enrollment ICMJE | 75 | |||
Actual Study Completion Date ICMJE | April 2008 | |||
Actual Primary Completion Date | April 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (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 | Belgium, France, Germany, Portugal, Spain, Sweden, Switzerland, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00143312 | |||
Other Study ID Numbers ICMJE | A1501038 | |||
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 | European Group for Blood and Marrow Transplantation | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |