Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Pfizer
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00904995

Purpose

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 standard assessment criteria used to diagnose invasive fungal infection in patients (pts) with hematologic malignancies.

Condition	Intervention	Phase
Leukemia Fungal Infection	Drug: Voriconazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Kinetics of 1, 3 Beta-d- Glucan Assay in Patients With Hematologic Malignancies Receiving Voriconazole Prophylaxis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Leukemia, Adult Acute Leukemia, Adult Chronic Molds

Drug Information available for: Voriconazole

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

False Positive Rate [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	May 2009
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental Only take pills (by mouth) of study drug 2 times every day.	Drug: Voriconazole Group 1: Starting dose of 400 mg by mouth twice a day for first day, followed by 200 mg by mouth twice a day thereafter. Group 2: Receive 6 mg/kg by vein for first dose, followed by 200 mg by mouth twice a day thereafter.
Group 2: Experimental Receive study drug by vein 1 time when begin and then pills of study drug 2 times every day for the rest of the time on study.	Drug: Voriconazole Group 1: Starting dose of 400 mg by mouth twice a day for first day, followed by 200 mg by mouth twice a day thereafter. Group 2: Receive 6 mg/kg by vein for first dose, followed by 200 mg by mouth twice a day thereafter.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 (EORTC criteria).
Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0 mg/dl); or SGPT or SGOT > 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904995

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Pfizer

Investigators

Study Chair:

Jorge Cortes, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Jorge Cortes, MD / Professor )
Study ID Numbers:	2008-0443
Study First Received:	May 18, 2009
Last Updated:	October 29, 2009
ClinicalTrials.gov Identifier:	NCT00904995 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Leukemia
Cancer of the blood
Cancer of the bone marrow
Hematologic malignancy

Invasive fungal infection
Voriconazole
Vfend

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Neoplasms by Histologic Type
Hematologic Neoplasms
Hematologic Diseases
Infection
Pharmacologic Actions

Leukemia
Mycoses
Neoplasms
Neoplasms by Site
Antifungal Agents
Therapeutic Uses
Voriconazole

ClinicalTrials.gov processed this record on February 08, 2010