UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000568
Receipt No. R000000680
Scientific Title Evaluation of Clinical Effectiveness of High-dose Intravenous Immunoglobulin(HD-IVIg) Therapy in Pneumonia with Avian Influenza and Other Influenza
Date of disclosure of the study information 2006/12/29
Last modified on 2007/07/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of Clinical Effectiveness of High-dose Intravenous Immunoglobulin(HD-IVIg) Therapy in Pneumonia with Avian Influenza and Other Influenza
Acronym High-dose intravenous immunoglobulin(HD-IVIg) therapy in Pneumonia with severe Avian Influenza and other severe Influenza
Scientific Title Evaluation of Clinical Effectiveness of High-dose Intravenous Immunoglobulin(HD-IVIg) Therapy in Pneumonia with Avian Influenza and Other Influenza
Scientific Title:Acronym High-dose intravenous immunoglobulin(HD-IVIg) therapy in Pneumonia with severe Avian Influenza and other severe Influenza
Region
Japan Asia(except Japan)

Condition
Condition Severe avian influenza and other severe influenza pneumonia
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of the treatment with the High-dose Intravenous immunoglobulin(HD-IVIg) for patients with avian influenza and other influenza pneumonia of moderate and severe cases in Vietnam and Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survival at day 5, day 10 and day 30 after start of the treatment.
If possible, the usefulness of this method for treatment will be compeared with historical cases.
Key secondary outcomes Feaver,X-ray,and Chest CT findings, laboratory data, blood chemistry, blood gas analysys MPO and Cytokines levels in serum.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 High dose immunoglobulin 2g/kg/BW/day in addition to the basic 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. Criteria of moderate and severe pneumonia
-Necessity of hospitalization (decided by a clinical doctor)
-And some symptoms, such as fever, cough, breathlessness.
-And one of the four following clinical findings.
1)New infilitration lesion detected on the first CXR or newly occurred among the film series.
2)Dyspnea, which manifests by:
Rapid breath rate defined by
30/min for adults and children more than 12 y.o.
40/min for children from 7 - 12y.o.
45/min for children from 4 - 6 y.o.
50/min for children from 1 - 3 y.o.
3)Respiratory muscle retraction.
4)SpO2 < 92% or Pa02 < 80 Torr

2. Criteria for definitive avian influenza pneumonia: The definitive diagnosis is made when the patient:
a) is diagnosed as moderate or severe pneumonia following the above-mentioned criteria.
b) and H5N1 positive

3. Criteria for definitive other influenza pneumonia: The definitive diagnosis is made when the patient:
a) is diagnosed as moderate or severe pneumonia following the above-mentioned criteria.
b) and test of other influenza viruses reveals positive

4. Criteria for suspected avian influenza pneumonia: when the patient:
a) is diagnosed as moderate or severe pneumonia following the above-mentioned criteria.
b) has a contact history with sick or died poultry

5. Criteria for suspected other influenza pneumonia; when the patient
a) is diagnosed as moderate or severe pneumonia following the above-mentioned criteria.
b) has a contact history with other influenza cases.
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 who suffer from side effect(s) of H-IVIg and have to stop the transfusion.
4) Individuals who are transferred to other hospitals/departments which make the observation impossible.
5) Individuals who suffer from underlying diseases, which become severe when they get this disease(avian or other human influenza pneumonia)
6) Individual with Severe congestive heart failure
7) Individual with IgA deficiency
8)Individual with risk of thrombo-embolism
9)Individual with hemolytic anemia
10) Individual with Immune deficiency
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Kudo/Nguen Duc Hien
Organization International Medical Center of Japan (IMCJ)<Japan>
National Institute for Infectious and Tropical Disease(NIITD)<Vietnam>
Division name Disease Control and Prevention Center (DCC) / National Institute for Infectious and Tropical Disease(NIITD)
Zip code
Address 1-21-1 Toyama, Shinjyuku-ku, Tokyo, Japan(DCC) / 78 Giai Phong Str-Hanoi, Vietnam(NIITD)
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Kudo
Organization International Medical Center of Japan (IMCJ)
Division name Disease Control and Prevention Center (DCC)
Zip code
Address
TEL
Homepage URL
Email kkudo@imcj.hosp.go.jp

Sponsor
Institute Japan:
International Medical Center of Japan
Vietnam:
National Institute for Infectious and Tropical Diseases, Bach Mai hospital, National Hospital of Pediatrics and other hospitals in Vietnam.
Institute
Department

Funding Source
Organization RIKEN Center of Research Network for Infectious Diseases (CRNID),Japanese Ministry of Education Culture, Sports, Service and Technology.
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
2006 Year 12 Month 29 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
The suspected case was entried as the first one in the trial study at NIITD Hanoi, Vietnam, June 2007.
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
Date of protocol fixation
2006 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2008 Year 05 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
2006 Year 12 Month 28 Day
Last modified on
2007 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000680

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.