UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010411 |
|---|---|
| Receipt number | R000012176 |
| Scientific Title | A randomized controlled trial to compare empiric antifungal therapy and D-index-guided early therapy during neutropenia. (CEDMIC trial) |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2018/02/20 10:29:18 |
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Basic information
Public title
A randomized controlled trial to compare empiric antifungal therapy and D-index-guided early therapy during neutropenia. (CEDMIC trial)
Acronym
RCT to compare empiric antifungal therapy and D-index-guided early therapy (CEDMIC trial)
Scientific Title
A randomized controlled trial to compare empiric antifungal therapy and D-index-guided early therapy during neutropenia. (CEDMIC trial)
Scientific Title:Acronym
RCT to compare empiric antifungal therapy and D-index-guided early therapy (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 test the non-inferiority of D-index-guided early antifungal therapy compared to empiric therapy during neutropenia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Proven/Probable invasive fungal infection
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
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
D-index-guided early antifungal therapy
Interventions/Control_2
Empiric antifungal therapy
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 | |
| Middle name | |
| Last name | Yoshinobu Kanda |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Hematology
Zip code
Address
Amanuma 1-847, Omiya, Saitama, Japan
TEL
048-647-2111
ycanda-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kanda |
Organization
Japan Febrile Neutropenia Study Group
Division name
Japan Febrile Neutropenia Study Group
Zip code
Address
Jonan, Fukuoka-city
TEL
092-801-2845
Homepage URL
http://www.fnkenkyu.com/index.html
ycanda-tky@umin.ac.jp
Sponsor or person
Institute
Japan Febrile Neutropenia Study Group
Institute
Department
Personal name
Funding Source
Organization
Astellas
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.fnkenkyu.com/index.html
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Not fixed
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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 03 | Day |
Last modified on
| 2018 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012176
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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