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
N/A
N/A
Both
Acute Leukemia
Trial Information
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
Inclusion Criteria:
- Acute leukemia (including myelogenous and lymphocytic) patients for remission
induction chemotherapy, reinduction chemotherapy and consolidation chemotherapy whose
antifungal treatment include voriconazole.
- Patients have been subscribed voriconazole for probable or proven fungal infections
by microbiological/cytohistological evidence from fine needle aspirate or
bronchoalveolarlavage means.
- Patients will also have imaging positive from lose dose CT results depicting halo
signs or crescent signs suggestive of invasive fungal infections.
- Patients must be able to tolerate oral intake of medications.
Exclusion Criteria:
- Patients unable to tolerate oral administration with any combinations of severe
mucositis (> or = grade 3), nausea/vomiting (> or = grade 3), diarrhea (> or =grade
2), neutropenic enterocolitis (> or = grade3).
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
To determine whether clinical responses (complete/partial/failure) directly correlate with patients' blood voriconazole levels.
Outcome Description:
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
Outcome Time Frame:
4 years
Safety Issue:
No
Principal Investigator
Jack Seki, P.Ph, PharmD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Toronto
Authority:
Canada: Ethics Review Committee
Study ID:
PMH-VOR
NCT ID:
NCT01321372
Start Date:
June 2007
Completion Date:
June 2011
Related Keywords:
- Acute Leukemia
- Leukemia
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