UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003669 |
|---|---|
| Receipt number | R000004448 |
| Scientific Title | Clinical research for hemoperfusion therapy with an immobilized polymyxin B (PMX) fiber column in patients with severe influenza pneumonia in Vietnam and Japan |
| Date of disclosure of the study information | 2010/05/27 |
| Last modified on | 2019/03/27 20:57:21 |
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Basic information
Public title
Clinical research for hemoperfusion therapy with an immobilized polymyxin B (PMX) fiber column in patients with severe influenza pneumonia in Vietnam and Japan
Acronym
Clinical research for hemoperfusion therapy in patients with severe influenza pneumonia
Scientific Title
Clinical research for hemoperfusion therapy with an immobilized polymyxin B (PMX) fiber column in patients with severe influenza pneumonia in Vietnam and Japan
Scientific Title:Acronym
Clinical research for hemoperfusion therapy in patients with severe influenza pneumonia
Region
| Japan | Asia(except Japan) |
Condition
Condition
severe influenza pneumonia
Classification by specialty
| Pneumology | Infectious disease | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical research is aimed to investigate the efficacy of direct hemoperfusion (DHP) with an immobilized polymyxin B (PMX) fiber column (PMX-DHP) in patients with severe influenza pneumonia in Vietnam and Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
survival
Key secondary outcomes
serial changes in blood test, levels of inflammatory mediators, physical findings and radiolgical images
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Blood purification therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Infection with influenza A virus is suspected.
The definitive diagnosis is made when the specimens obtained from the patient are A positive by Polymerase Chain Reaction (PCR) method or rapid test kit.
(2) The patient with moderate or severe pneumonia.
1) New infiltration lesion detected on the first CXR or newly occurred among the film series.
2) The patient who fulfills PaO2/FiO2 ratio of 80-300.
(3) The patient whose symptom onset is no later than 7 days.
(4) The patient from whom (or whose deputy) a written consent is obtained.
Key exclusion criteria
(1) Individuals who do not meet the above mentioned criteria for cases.
(2) Individuals who do not agree to sign the informed consents.
(3) Individuals with Immune deficiency.
(4) Individuals who are decided to be NOT suitable for this research by a clinical doctor.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Kudo |
Organization
National Center for Globsl Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
Address
1-21-1 Toyama, Shinjuku-Ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jin Takasaki |
Organization
National Center for Globsl Health and Medicine
Division name
Disease Control and Prevention Center/Departmant of Respiratory Medicine
Zip code
Address
TEL
0332027181
Homepage URL
jin@dcc.go.jp
Sponsor or person
Institute
Disease Control and Prevention Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan
Organization
Division
Category of Funding 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
| 2010 | Year | 05 | Month | 27 | 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
| 2008 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2008 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004448
| 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 |
