Phase 3
Completed N=21
Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis
Source: ClinicalTrials.gov NCT00904995 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Percentage of Samples With BG Levels > 60pg/ml — 4; 5; 3; 3 percent of blood samples
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Samples With BG Levels > 60pg/ml |
4; 5; 3; 3 | — |
Eligibility 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 (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.
Data sourced from ClinicalTrials.gov (NCT00904995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.