Phase 3 N=21 Randomized Treatment

Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis

Leukemia · Fungal Infection

Bottom Line

View on ClinicalTrials.gov: NCT00904995 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2011

Primary outcome: Primary: Percentage of Samples With BG Levels > 60pg/ml — 4; 5; 3; 3 percent of blood samples

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Voriconazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Samples With BG Levels > 60pg/ml	4; 5; 3; 3	—

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.

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.

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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.