Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis
NCT00904995
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1. Diagnosis of hematologic malignancy with indication to receive antifungal prophylaxis.
2. Age >/= 18 years.
3. Patients must sign an informed consent.
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.
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Descriptive Information | ||||
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Brief Title ICMJE | Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis | |||
Official Title ICMJE | Kinetics of 1, 3 Beta-d- Glucan Assay in Patients With Hematologic Malignancies Receiving Voriconazole Prophylaxis | |||
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 standard assessment criteria used to diagnose invasive fungal infection in patients with hematologic malignancies. | |||
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 part of the fungal cell floating freely in the human blood. When certain drugs are given to patients to prevent fungal infections, these blood tests may show that there is an infection when there actually is not one present. Some of these drugs are similar to the study drug voriconazole. The Study Drug: Voriconazole is designed to slow the growth of fungal cells, which may cause the fungal cells to die. Screening Tests: Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you. Study Groups: If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 study groups. Group 1 will consist of the first 10 patients enrolled on the study. Group 2 will consist of the next 10 patients enrolled on the study. If you are in Group 1, you will take only pills of study drug 2 times every day while you are on study. If you are in Group 2, you will receive the study drug through a needle in your vein 1 time when you begin the study and then take pills of study drug 2 times every day for the rest of the time you are on study. Blood Draws for Fungal Infection Tests: If you are in Group 1, blood (about 1 teaspoon each time) will be drawn for fungal infection tests at the following times:
If you are in Group 2, blood (about 1 teaspoon each time) will be drawn for fungal infection tests at the following times:
Length of Study: You may continue taking the study drug for up to 35 days if you are receiving chemotherapy for the first time and up to 42 days if you have had chemotherapy before. Your doctor may decide that you should take the study drug for an even longer period of time or that you need to have another drug to prevent fungal infections. You will be taken off study if intolerable side effects occur or if you get a fungal infection. Additional Information: There are several drugs that should not be taken in combination with voriconazole. You should talk to the study doctor about any drugs you may be taking and about any drugs you may plan to start taking while on study. You should also avoid eating/drinking grapefruit/grapefruit products while you are on study, as they may interfere with the effects of the study drug. This is an investigational study. Voriconazole is FDA approved and commercially available for the treatment of fungal infections. Up to 20 patients who are found to be eligible after screening will take part in this study. All will be enrolled at M. D. Anderson. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 23 | |||
Original Estimated Enrollment ICMJE | 20 | |||
Actual Study Completion Date ICMJE | July 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00904995 | |||
Other Study ID Numbers ICMJE | 2008-0443 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | M.D. Anderson Cancer Center | |||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | |||
Verification Date | August 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |