NCT01321372

An Observational Analysis of Voriconazole Therapeutic Drug Concentration Monitoring, Pharmacogenomics and Clinical Outcome Correlations in High-risk Hematology Patients

A Prospective, Observational Analysis of Voriconazole (VOR) Therapeutic Drug Concentration Monitoring, Pharmacogenomics and Clinical Outcome Correlations in High-risk Hematology Patients at Princess Margaret Hospital

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 82 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Hematology patients are at high risk for invasive fungal infection (IFI) and are being treated with voriconazole (VOR) at Princess Margaret Hospital (PMH). It is critical that patients' serum drug levels are within therapeutic ranges when undergoing treatment. The primary objective of this study is to determine whether clinical responses (complete/partial/failure) directly correlate with patients' blood VOR drug levels. In patients whose disease progression is associated with inadequate voriconazole (VOR) drug levels, serum drug level determination can allow for dose adjustment, thereby preventing disease progression. Patients who are extensive metabolizers may have subtherapeutic VOR levels leading to treatment failure whereas, poor metabolizers may have high drug levels that cause toxicity. Isoenzyme such as CYP2C19 exhibits genetic polymorphism. Genotyping tests can also be helpful in determining patient risk subjecting to extreme spectrum of drug levels.

Conditions

• Acute Leukemia

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-02-01
• Completion: 2011-06-01
• First posted: 2011-03-23
• Last updated: 2013-03-19

Locations

1 site across 1 country: Canada