Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Pfizer
• Treatments: Voriconazole

Criteria

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.