Efficacy of dose modification based on therapeutic drug monitoring of voriconazole in the treatment of invasive fungal infections associated with hematological diseases
Not Applicable
- Conditions
- Invasive fungal infections associated with hematological diseases
- Registration Number
- JPRN-UMIN000005639
- Lead Sponsor
- Department of Hematology and Oncology, University of Tokyo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
a. QT elongation (QTc > 0.46 ms) by EKG b. Patients who are susceptible to fatal arrythmias such as ventricular tachycardia c. Use of contraindicated drugs at enrollment: rifampicin, rifabutin, efavirenz, rithnavir, carbamazepine, barbital, phenobarbital, pymozide, quinidine, ergotamine(alkaloids), triazolam, bepridil, simvastatin, azelnidipine, nisoldipine, vardenafil, eplerenone, blonanserin, sildenafil, tadalafil. d. Concomitant use of other antifungal agents unless they can be stopped at the time of enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Achievement of target trough voriconazole level of 2 - 6 mg/L, on day 15 of the treatment
- Secondary Outcome Measures
Name Time Method - Dose of oral voriconazole - Radiological and clinical response rate - Serological response rate, using galactomannan antigen EIA or beta-D-glucan levels - Incidence of adverse events, graded using the NCI-CTCAE version 3.0