UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005639 |
|---|---|
| Receipt number | R000006661 |
| Scientific Title | Efficacy of dose modification based on therapeutic drug monitoring of voriconazole in the treatment of invasive fungal infections associated with hematological diseases |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2015/06/30 13:35:10 |
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Basic information
Public title
Efficacy of dose modification based on therapeutic drug monitoring of voriconazole in the treatment of invasive fungal infections associated with hematological diseases
Acronym
Efficacy of dose modification based on therapeutic drug monitoring of voriconazole in the treatment of invasive fungal infections associated with hematological diseases
Scientific Title
Efficacy of dose modification based on therapeutic drug monitoring of voriconazole in the treatment of invasive fungal infections associated with hematological diseases
Scientific Title:Acronym
Efficacy of dose modification based on therapeutic drug monitoring of voriconazole in the treatment of invasive fungal infections associated with hematological diseases
Region
| Japan |
Condition
Condition
Invasive fungal infections associated with hematological diseases
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to develop an effective administration schedule of oral voriconazole in the treatment of invasive fungal infections associated with hematological diseases. Since clinical effectiveness and the incidence of adverse effects are dependent on the trough levels, adjusting the dose to achieve effective serum concentration is important when using voriconazole for the treatment of invasive fungal infections. Since trough levels of voriconazole is mainly dependent of the metabolism via CYP2C19, optimal initial dose of this drug is unpredictable, and it is important to adjust the dose according to serum levels to achieve an effective serum concentration of 2 – 6 mg/L. In this study, we monitor the level of voriconazole in the treatment of fungal infections in hematological disease, and elucidate whether monitored dose scheduling of voriconazole is effective in achieving the optimal therapeutic dose.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Achievement of target trough voriconazole level of 2 - 6 mg/L, on day 15 of the treatment
Key secondary outcomes
- 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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
- 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 voriconazole levels from the next dose after the trough level is reported.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoshi Ichikawa |
Organization
University of Tokyo Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo Japan
TEL
+81-3-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoshi Ichikawa |
Organization
University of Tokyo Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
TEL
Homepage URL
motoshi-tky@umin.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology and Oncology, University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学医学部附属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2011 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 24 | Day |
Last modified on
| 2015 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006661
