UMIN ID: UMIN000000568
Registered date:29/12/2006
Evaluation of Clinical Effectiveness of High-dose Intravenous Immunoglobulin(HD-IVIg) Therapy in Pneumonia with Avian Influenza and Other Influenza
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Severe avian influenza and other severe influenza pneumonia |
| Date of first enrollment | 2006/08/01 |
| Target sample size | 15 |
| Countries of recruitment | Japan,Asia(except Japan) |
| Study type | Interventional |
| Intervention(s) | High dose immunoglobulin 2g/kg/BW/day in addition to the basic therapy |
Outcome(s)
| Primary Outcome | 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. |
|---|---|
| Secondary Outcome | Feaver,X-ray,and Chest CT findings, laboratory data, blood chemistry, blood gas analysys MPO and Cytokines levels in serum. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | 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. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | RIKEN Center of Research Network for Infectious Diseases (CRNID),Japanese Ministry of Education Culture, Sports, Service and Technology. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Koichiro Kudo |
| Address | Japan |
| Telephone | |
| kkudo@imcj.hosp.go.jp | |
| Affiliation | International Medical Center of Japan (IMCJ) Disease Control and Prevention Center (DCC) |
| scientific contact | |
| Name | Koichiro Kudo/Nguen Duc Hien |
| Address | 1-21-1 Toyama, Shinjyuku-ku, Tokyo, Japan(DCC) / 78 Giai Phong Str-Hanoi, Vietnam(NIITD) Japan |
| Telephone | |
| Affiliation | International Medical Center of Japan (IMCJ)<Japan> National Institute for Infectious and Tropical Disease(NIITD)<Vietnam> Disease Control and Prevention Center (DCC) / National Institute for Infectious and Tropical Disease(NIITD) |