Unique ID issued by UMIN | UMIN000046739 |
---|---|
Receipt number | R000053326 |
Scientific Title | A prospective observational study on host immunity for development of novel immunotherapeutic strategy in patients with severe respiratory tract infections and sepsis |
Date of disclosure of the study information | 2022/01/26 |
Last modified on | 2022/01/26 18:42:57 |
A prospective observational study on host immunity for development of novel immunotherapeutic strategy in patients with severe respiratory tract infections and sepsis
An observational study on immunity in patients with severe respiratory tract infections and sepsis
A prospective observational study on host immunity for development of novel immunotherapeutic strategy in patients with severe respiratory tract infections and sepsis
A prospective observational study on host immunity in patients with severe respiratory tract infections and sepsis
Japan |
Community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), coronavirus disease 2019 (COVID-19), and sepsis
Pneumology | Infectious disease |
Others
YES
To determine the host immune characteristics in patients with severe respiratory tract infections and sepsis
Others
To make recommendations/suggestions that will lead to the development of novel therapeutic strategies for severe respiratory tract infections and sepsis
Exploratory
Not applicable
1) Clinical outcomes
Death, progression to severe state, secondary adverse events, and treatment failure
2) Immunological outcome
Association between host immune characteristics and clinical outcomes
Observational
20 | years-old | <= |
90 | years-old | >= |
Male and Female
Patients with pneumonia or sepsis.
- Pneumonia is defined as the presence of a new infiltrate on a chest X-ray, or a computed tomography scan, plus at least one of the following criteria: 1) cough or purulent sputum, 2) pleuritic chest pain, 3) dyspnea, 4) fever or hypothermia (temperature >= 37.5 degrees or < 35 degrees), 5) white blood cell count >= 10,000 /mm3 or < 4,000 /mm3, 6) increase of CRP or PCT values above the upper limit of facility reference value and 7) hypoxemia (SpO2 < 90% or PaO2 < 60 Torr) or decline in oxygenation.
- COVID-19 is confirmed by a positive polymerase-chain-reaction test or antigen test.
- Sepsis is defined as the presence of a clear infection or suspected infection with the Sequential Organ Failure Assessment (SOFA) score of 2 points or more increase from the baseline score (if the baseline SOFA score before the onset of sepsis is unknown and presumed to be free of organ damage, the baseline SOFA score is considered to be 0).
1) Patients who do not receive initial empirical antibiotic treatment
2) Patients with obstructive pneumonia
3) Pneumonia or sepsis occurred in other hospitals and patients who were transferred from other hospitals with a trend toward improvement
4) Patients whose pneumonia or sepsis recurred within 3 days after the last day of antibiotic treatment of a preceding pneumonia or sepsis episode
5) Patients who receive the treatment in outpatient clinics
6) Patients who were enrolled in this study previously
7) Patients over 90 years old
8) HIV positive patients
9) Pregnant women
10) Patients with neutropenia (neutrophil counts <1,000/mm3)
11) Patients with active hematologic malignancies
12) Patients after blood stem cell transplants, including bone marrow transplants
13) Patients treated for co-morbidities with high-dose glucocorticoid
650
1st name | Yuichiro |
Middle name | |
Last name | Shindo |
Nagoya University Hospital
Respiratory Medicine
466-8550
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
0527442167
yshindo@med.nagoya-u.ac.jp
1st name | Yuichiro |
Middle name | |
Last name | Shindo |
Nagoya University Hospital
Respiratory Medicine
466-8550
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
0527442167
yshindo@med.nagoya-u.ac.jp
Nagoya University Hospital
Japan Society for the Promotion of Science, Grants-in-Aid for Scientific Research
Japanese Governmental office
Japan
Nagoya University Hospital, Institutional Review Board
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
0527442423
iga-shinsa@adm.nagoya-u.ac.jp
NO
名古屋大学医学部附属病院(愛知県)
公立陶生病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
トヨタ記念病院(愛知県)
名古屋掖済会病院(愛知県)
日本赤十字社愛知医療センター名古屋第二病院(愛知県)
JA愛知厚生連豊田厚生病院(愛知県)
豊橋市民病院(愛知県)
中東遠総合医療センター(静岡県)
中部労災病院(愛知県)
常滑市民病院(愛知県)
小牧市民病院(愛知県)
名城病院(愛知県)
中京病院(愛知県)
岐阜県立多治見病院(岐阜県)
春日井市民病院(愛知県)
名古屋市立大学医学部附属東部医療センター(愛知県)
愛知県厚生農業協同組合連合会海南病院(愛知県)
愛知県厚生農業協同組合連合会知多厚生病院(愛知県)
愛知県厚生農業協同組合連合会豊田厚生病院(愛知県)
愛知県立愛知病院(愛知県)
医療法人豊田会刈谷豊田総合病院(愛知県)
三重大学医学部附属病院(三重県)
岐阜大学医学部附属病院(岐阜県)
愛知医科大学病院(愛知県)
藤田医科大学病院(愛知県)
(※予定含む)
2022 | Year | 01 | Month | 26 | Day |
Unpublished
Enrolling by invitation
2019 | Year | 10 | Month | 29 | Day |
2019 | Year | 11 | Month | 19 | Day |
2019 | Year | 11 | Month | 19 | Day |
2026 | Year | 03 | Month | 31 | Day |
- This study is an observational study.
- Collection of clinical information and blood samples are performed in each study institution. Immunological analyses of blood samples will be performed at Nagoya University Graduate School of Medicine.
2022 | Year | 01 | Month | 26 | Day |
2022 | Year | 01 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053326