Efficacy of dose modification based on therapeutic drug monitoring of voriconazole in the treatment of invasive fungal infections associated with hematological diseases

Efficacy of dose modification based on therapeutic drug monitoring of voriconazole in the treatment of invasive fungal infections associated with hematological diseases - Efficacy of dose modification based on therapeutic drug monitoring of voriconazole in the treatment of invasive fungal infections associated with hematological diseases

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005639

Enrollment

Registered

2011-06-01

Start date

2011-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive fungal infections associated with hematological diseases

Interventions

- Treatments Voriconazole 300 mg bid p.o. day 1, followed by 200 mg bid p.o. day 2- - Adjustments according to trough plasma levels Dose of voriconazole is adjusted according to the trough voricon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients who meet all of the following criteria: a. Patients under treatment for hematological malignancies (e.g., leukemia or lymphomas) b. Diagnosed as having at least possible invasive fungal infection according to the 2008 EORTC/MSG criteria c. Patients who do not have severe hepatic failure (>=Child C) d. Patients who are expected to survive at least 1 month from the time of enrollment e. Major organ functions are preserved: Total bilirubin : below or equal to 2.0 mg/dL AST, ALT, ALP : below 3.0 x upper normal limit Serum creatinine <= 2.0 mg/dL Arterial oxygen saturation (by pulse oxymeter) : at least 90% f. Age : at least 20 years at the time of informed concent g. Body weight : at least 40 kg h. Patients who will be hospitalized until day 15 of therapy

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Achievement of target trough voriconazole level of 2 - 6 mg/L, on day 15 of the treatment	—

Secondary

Measure	Time frame
- 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	—

Countries

Japan

Contacts

Public ContactMotoshi Ichikawa

University of Tokyo Hospital Department of Hematology and Oncology

motoshi-tky@umin.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026