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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000630
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Division of hematology,Iwate medical unversity
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000748

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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