An Observational Analysis of Voriconazole Therapeutic Drug Concentration Monitoring, Pharmacogenomics and Clinical Outcome Correlations in High-risk Hematology Patients
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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|
- To determine whether clinical responses (complete/partial/failure) directly correlate with patients' blood voriconazole levels. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
The primary outcome measure is defined by the following endpoints:
- abefrile for at least 48 hours
- no breakthrough fungal infection
- resolution or improvement of radiological findings
- The secondary objective of this study will focus on clinical toxicity, organ involvement and survival. [ Time Frame: 4 years ] [ Designated as safety issue: No ]The secondary outcome of the study is defined as resolution of renal or hepatic dysfunction and survival.
|Study Start Date:||June 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321372
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Jack Seki, P.Ph, PharmD||University Health Network, Toronto|