UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000630 |
|---|---|
| Receipt number | R000000748 |
| Scientific Title | Voriconazole versus Micafungin for empirical antifungal therapy in patients with neutropenia and persistent fever |
| Date of disclosure of the study information | 2008/12/31 |
| Last modified on | 2012/03/24 10:15:43 |
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Basic information
Public title
Voriconazole versus Micafungin for empirical antifungal therapy in patients with neutropenia and persistent fever
Acronym
Voriconazole versus Micafungin in patients with FN
Scientific Title
Voriconazole versus Micafungin for empirical antifungal therapy in patients with neutropenia and persistent fever
Scientific Title:Acronym
Voriconazole versus Micafungin in patients with FN
Region
| Japan |
Condition
Condition
febril neutropenia
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A comparison between Voriconazole and Micafungin for empirical antifungal therapy in patients with neutropenia and persistent fever
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
defervesce and survival rate after two and four weeks from starting treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Micafugin150mg iv once a day
Interventions/Control_2
Voriconazole 6mg/kg iv twice a day on day1,followed by 4mg/kg iv twice daily
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)fever with tempreture above 38.0 degree. 2)neutropenia(<500cells/uL)for at least 4days. 3)injectable antibacterials for at least 4days.
Key exclusion criteria
1)AST/ALT/total bilirubin>5 times the upper limit of normal(at each institution).2)Karnofsky score<30%.3)Documented invasive fungal infection before starting treatment.4)History of treatment by voriconazole or mycafungin.5)History of allergy or hypersensitivity to voriconazole or mycafungin.6)Not eligible for the study in the opinion of investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoji Ishida |
Organization
Iwate Medical unversity
Division name
Hematology
Zip code
Address
19-1 utimaru morioka Iwate Janpan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Iwate Medical unversity
Division name
Hematology
Zip code
Address
TEL
019-651-5111
Homepage URL
Sponsor or person
Institute
Division of hematology,Iwate medical unversity
Institute
Department
Personal name
Funding Source
Organization
Division of hematology,Iwate medical unversity
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2007 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 03 | Month | 06 | Day |
Last modified on
| 2012 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000748
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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