Status:
COMPLETED
Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Pfizer
Conditions:
Leukemia
Fungal Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Objectives: To investigate the relationship between the administration of intravenous (IV) and oral voriconazole (vori) and the occurrence of false positive (1,3) beta-d- glucan (BG) relative to the ...
Detailed Description
Chemotherapy can lower immune system function, which can cause fungal infections to occur more easily. These fungal infections are found by certain blood tests. One of these blood tests looks for a pa...
Eligibility Criteria
Inclusion
- Diagnosis of hematologic malignancy with indication to receive antifungal prophylaxis.
- Age \>/= 18 years.
- Patients must sign an informed consent.
Exclusion
- Patients with history of anaphylaxis attributed to azole compounds: voriconazole, itraconazole, fluconazole, posaconazole
- Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment (European Organisation for Research and Treatment of Cancer (EORTC) criteria).
- Patients with total bilirubin levels \> 3 times the upper normal limits (i.e. \> 3.0 mg/dl); or aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT)\> 5 times upper limit normal.
- Patients receiving any medication that is contraindicated with the use of voriconazole. Voriconazole is contraindicated with the co-administration of the following drugs:sirolimus, terfenadine, astemizole, cisapride, pimozide, quinidine, ergot alkaloids, rifabutin, rifampin, high-dose ritonavir (400 mg Q12h), carbamazepine, long-acting barbiturates, efavirenz (with standard dose vfend and efavirenz), St. John's Wort.
- Patients currently receiving voriconazole for antifungal prophylaxis.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00904995
Start Date
May 1 2009
End Date
July 1 2010
Last Update
August 7 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030