Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis
|ClinicalTrials.gov Identifier: NCT00904995|
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : May 12, 2011
Last Update Posted : August 7, 2012
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 standard assessment criteria used to diagnose invasive fungal infection in patients with hematologic malignancies.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Fungal Infection||Drug: Voriconazole||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Kinetics of 1, 3 Beta-d- Glucan Assay in Patients With Hematologic Malignancies Receiving Voriconazole Prophylaxis|
|Study Start Date :||May 2009|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
Experimental: Group 1 - Oral
Voriconazole Starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
Starting dose of 400 mg by mouth twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
Other Name: Vfend
Experimental: Group 2 - IV + Oral
Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
6 mg/kg by vein for first dose, followed by 200 mg by mouth twice a day thereafter.
Other Name: Vfend
- Percentage of Samples With BG Levels > 60pg/ml [ Time Frame: Up to 42 days ]
Rate calculated as number of participants with positive levels divided by total number of participants. beta-d-glucan (BG), a cell wall constituent of fungi, can be detected in serum as a marker of Invasive fungal infections (IFI).
Blood samples were drawn on first 2 days of treatment at baseline (before the drug) and at 1, 2, 4, 8 hours after the first dose of the day. BG serum levels were measured using the Fungitell assay, using a cut off value of 60 pg/ml for positivity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904995
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Jorge Cortes, MD||UT MD Anderson Cancer Center|