UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040390 |
|---|---|
| Receipt number | 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 19:23:57 |
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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
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
aokamoto@fujita-hu.ac.jp
Sponsor or person
Institute
Japan Febrile Neutropenia Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046089
