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Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00904995
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : May 12, 2011
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Kinetics of 1, 3 Beta-d- Glucan Assay in Patients With Hematologic Malignancies Receiving Voriconazole Prophylaxis
Study Start Date : May 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Voriconazole
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.
Drug: Voriconazole
6 mg/kg by vein for first dose, followed by 200 mg by mouth twice a day thereafter.
Other Name: Vfend

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of hematologic malignancy with indication to receive antifungal prophylaxis.
  2. Age >/= 18 years.
  3. Patients must sign an informed consent.

Exclusion Criteria:

  1. Patients with history of anaphylaxis attributed to azole compounds: voriconazole, itraconazole, fluconazole, posaconazole
  2. 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).
  3. 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.
  4. 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.
  5. Patients currently receiving voriconazole for antifungal prophylaxis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00904995

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Study Chair: Jorge Cortes, MD UT MD Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00904995    
Other Study ID Numbers: 2008-0443
First Posted: May 20, 2009    Key Record Dates
Results First Posted: May 12, 2011
Last Update Posted: August 7, 2012
Last Verified: August 2012
Keywords provided by M.D. Anderson Cancer Center:
Cancer of the blood
Cancer of the bone marrow
Hematologic malignancy
Invasive fungal infection
antifungal prophylaxis
Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors