UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000568 |
|---|---|
| Receipt number | 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 09:52:06 |
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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
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
kkudo@imcj.hosp.go.jp
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000680
| 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 |
