UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021476 |
|---|---|
| Receipt number | R000024768 |
| Scientific Title | Anti-inflammatory and immunomodulative effects of clarithromycin for severe septic patients |
| Date of disclosure of the study information | 2016/03/15 |
| Last modified on | 2016/03/15 11:41:47 |
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Basic information
Public title
Anti-inflammatory and immunomodulative effects of clarithromycin for severe septic patients
Acronym
Anti-inflammatory and immunomodulative effects of clarithromycin
Scientific Title
Anti-inflammatory and immunomodulative effects of clarithromycin for severe septic patients
Scientific Title:Acronym
Anti-inflammatory and immunomodulative effects of clarithromycin
Region
| Japan |
Condition
Condition
severe sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate anti-inflammatory and immunomodulative effects of clarithromycin for severe septic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
inflammatory cytytokines
Key secondary outcomes
Number and function of immuno cells
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult severe septic patients in Tokai University hospital
Key exclusion criteria
Under 18.y.o
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeaki Inoue |
Organization
Tokai University hospital
Division name
Dept of Emergency medicine
Zip code
Address
Shimokasuya 143, Isehara, Kanagawa
TEL
0463-93-1121
sg-inoue@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeaki Inoue |
Organization
Tokai University hospital
Division name
Dept of Emergency medicine
Zip code
Address
Shimokasuya 143, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
sg-inoue@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Inoue laboratory, Tokai University
Institute
Department
Personal name
Funding Source
Organization
Taisho toyama pharmaceutical co. ltd
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
| 2016 | Year | 03 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Collecting patients samples
Management information
Registered date
| 2016 | Year | 03 | Month | 15 | Day |
Last modified on
| 2016 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024768
