UMIN-CTR Clinical Trial

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