Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis

Completed · Phase 3

Conditions studied: Leukemia, Fungal Infection

In brief

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.

Key facts

Study ID

NCT00904995

Run by

M.D. Anderson Cancer Center

People needed

23

Starts

2009-05-01

Expected to finish

2010-07-01

Last updated by the study team

2012-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 (European Organisation for Research and Treatment of Cancer (EORTC) criteria).
• 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.
• 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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.