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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040390
Receipt No. R000046089
Scientific Title Analysis of Blood Culture and antibacterial Drugs in Classical empiric therapy vs. D-index-guided early therapy using micafungin for persistent febrile neutropenia.(ABCD-CEDMIC trial)
Date of disclosure of the study information 2020/05/13
Last modified on 2020/05/13

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Basic information
Public title Analysis of Blood Culture and antibacterial Drugs in Classical empiric therapy vs. D-index-guided early therapy using micafungin for persistent febrile neutropenia.(ABCD-CEDMIC trial)
Acronym Analysis of Blood Culture and antibacterial Drugs in RCT to compare empiric antifungal therapy and D-index-guided early therapy (ABCD-CEDMIC trial)
Scientific Title Analysis of Blood Culture and antibacterial Drugs in Classical empiric therapy vs. D-index-guided early therapy using micafungin for persistent febrile neutropenia.(ABCD-CEDMIC trial)
Scientific Title:Acronym Analysis of Blood Culture and antibacterial Drugs in RCT to compare empiric antifungal therapy and D-index-guided early therapy (ABCD-CEDMIC trial)
Region
Japan

Condition
Condition Hematological malignancies(acute leukemia, myelodysplastic syndrome, lymphoma, myeloma, and so on)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To detect the pathogens and confirm the risk factor and pathogens in blood culture positive febrile neutropenia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To detect the pathogens and confirm the risk factor
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients with hematological malignancies who undergo chemotherapy or stem cell transplantation
2)Aged between 16 and 79 years
3)Expected duration of neutropenia at least 7 days
4)No grade III-IV renal or liver dysfunction
5)ECOG-PS 0-2
6)Written informed consent obtained
Key exclusion criteria 1)Previous history of invasive fungal infection
2)Receiving antifungal agents other than prophylactic administration
3)Suspected active infection
4)Planned to receive antifungal prophylaxis with polyenes or candins
5)Allergic reaction to candins
6)Pregnant or possibly pregnant
7)HIV positive
8)Not suitable for thie trial judged by attending physicians
Target sample size 420

Research contact person
Name of lead principal investigator
1st name Yoshinobu
Middle name
Last name Kanda
Organization Saitama Medical Center, Jichi Medical University
Division name Division of Hematology
Zip code 330-0834
Address Amanuma 1-847, Omiya, Saitama, Japan
TEL 048-647-2111
Email nemi@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Akinao
Middle name
Last name Okamoto
Organization Fujita Health University School of Medicine
Division name Hematology
Zip code 4701192
Address 1-98, Dengakugakubo, Kutsukake-cho, Toyoake
TEL 0562939243
Homepage URL
Email aokamoto@fujita-hu.ac.jp

Sponsor
Institute Japan Febrile Neutropenia Study Group
Institute
Department

Funding Source
Organization Fujita health university
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 Fujita Health University School of Medicine
Address 1-98, Dengakugakubo, Kutsukake-cho, Toyoake
Tel 0562939243
Email f-irb@fujita-hu.ac.jp

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
2020 Year 05 Month 13 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 423
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 No longer recruiting
Date of protocol fixation
2020 Year 02 Month 02 Day
Date of IRB
2020 Year 04 Month 04 Day
Anticipated trial start date
2020 Year 04 Month 04 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We assessed about the cedmic trial (UMIN000010411) in back ground, risk factor and blood culture.

Management information
Registered date
2020 Year 05 Month 13 Day
Last modified on
2020 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046089

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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