UMIN-CTR Clinical Trial

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
Last 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
Email

Public contact
1st 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
Email	jin@dcc.go.jp

Sponsor
Institute	Disease Control and Prevention Center
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004448