Status:
COMPLETED
Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO)
Conditions:
Possible Fungal Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the number of white blood cells, especially of the so-called neutrophil granulocytes, which are very important for...
Eligibility Criteria
Inclusion
- Acute leukemia, aggressive lymphoma, bone marrow or stem cell transplantation;
- Neutropenia (\<500 neutrophils/µL) of at least 10 days;
- Newly diagnosed fever;
- Positive panfungal polymerase chain reaction assay
Exclusion
- Documented bacterial infection during screening or at randomization
- Fungemia or other documented invasive fungal infection during screening or at randomization.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00150345
Start Date
January 1 2005
End Date
April 1 2009
Last Update
January 19 2012
Active Locations (28)
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1
Pfizer Investigational Site
Augsburg, Germany, 86156
2
Pfizer Investigational Site
Berlin, Germany, 10117
3
Pfizer Investigational Site
Berlin, Germany, 12200
4
Pfizer Investigational Site
Berlin, Germany, 13353