UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006944 |
|---|---|
| Receipt number | R000008205 |
| Scientific Title | Randomized trial of doripenem or meropenem in the treatment of febrile neutropenia |
| Date of disclosure of the study information | 2012/01/05 |
| Last modified on | 2022/09/28 16:01:01 |
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Basic information
Public title
Randomized trial of doripenem or meropenem in the treatment of febrile neutropenia
Acronym
Randomized trial of doripenem or meropenem in FN
Scientific Title
Randomized trial of doripenem or meropenem in the treatment of febrile neutropenia
Scientific Title:Acronym
Randomized trial of doripenem or meropenem in FN
Region
| Japan |
Condition
Condition
patients with febrile neutropenia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of effectiveness and safety of doripenem or meropenem in the treatment of FN in hematological disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
effectiveness at 7days after the start of treatment
Key secondary outcomes
effectiveness at 3 and 5 days after the start of treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with doripenem
Interventions/Control_2
treatment with meropenem
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
fever over 38 degrees
neutrocyte less than 500/mm3
T.bil <2.0mg/dl
s-Cre<2.0mg/dl
Key exclusion criteria
allergic to carbapenem
LC
pregnant woman
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tanaka Junji |
Organization
Tokyo Women's Medical University
School of medicine
Division name
Department of hematology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
imaiyo@dh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Imai |
Organization
Tokyo Women's Medical University
Division name
Department of hematology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Toky
TEL
03-3353-8111
Homepage URL
imaiyo@dh.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical 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
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
| 2012 | Year | 01 | Month | 05 | 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
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
| 2011 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 24 | Day |
Last modified on
| 2022 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008205
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
