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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01321372
First received: March 21, 2011
Last updated: March 18, 2013
Last verified: March 2013

March 21, 2011
March 18, 2013
June 2007
February 2011   (final data collection date for primary outcome measure)
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:

  1. abefrile for at least 48 hours
  2. no breakthrough fungal infection
  3. resolution or improvement of radiological findings
Same as current
Complete list of historical versions of study NCT01321372 on ClinicalTrials.gov Archive Site
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.
Same as current
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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

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Acute leukemia (including myelogenous and lymphocytic) patients for remission induction chemotherapy, reinduction chemotherapy and consolidation chemotherapy whose antifungal treatment includes voriconazole.

Acute Leukemia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
June 2011
February 2011   (final data collection date for primary outcome measure)

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).
Both
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No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01321372
PMH-VOR
No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Jack Seki, P.Ph, PharmD University Health Network, Toronto
University Health Network, Toronto
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP