Severe avian influenza and other severe influenza pneumonia
Conditions
Interventions
High dose immunoglobulin 2g/kg/BW/day in addition to the basic therapy
Sponsors
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.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Feaver,X-ray,and Chest CT findings, laboratory data, blood chemistry, blood gas analysys MPO and Cytokines levels in serum. | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactKoichiro Kudo
International Medical Center of Japan (IMCJ) Disease Control and Prevention Center (DCC)
Outcome results
None listed