UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study on host immunity for development of novel immunotherapeutic strategy in patients with severe respiratory tract infections and sepsis
Acronym	An observational study on immunity in patients with severe respiratory tract infections and sepsis
Scientific Title	A prospective observational study on host immunity for development of novel immunotherapeutic strategy in patients with severe respiratory tract infections and sepsis
Scientific Title:Acronym	A prospective observational study on host immunity in patients with severe respiratory tract infections and sepsis
Region	Japan

Condition
Condition	Community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), coronavirus disease 2019 (COVID-19), and sepsis
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To determine the host immune characteristics in patients with severe respiratory tract infections and sepsis
Basic objectives2	Others
Basic objectives -Others	To make recommendations/suggestions that will lead to the development of novel therapeutic strategies for severe respiratory tract infections and sepsis
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	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
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	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).
Key exclusion criteria	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
Target sample size	650

Research contact person
Name of lead principal investigator	1st name Yuichiro Middle name Last name Shindo
Organization	Nagoya University Hospital
Division name	Respiratory Medicine
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	0527442167
Email	yshindo@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Yuichiro Middle name Last name Shindo
Organization	Nagoya University Hospital
Division name	Respiratory Medicine
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	0527442167
Homepage URL
Email	yshindo@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science, Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University Hospital, Institutional Review Board
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel	0527442423
Email	iga-shinsa@adm.nagoya-u.ac.jp

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

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)

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 26 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
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	Enrolling by invitation
Date of protocol fixation	2019 Year 10 Month 29 Day
Date of IRB	2019 Year 11 Month 19 Day
Anticipated trial start date	2019 Year 11 Month 19 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	- 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.

Management information
Registered date	2022 Year 01 Month 26 Day
Last modified on	2022 Year 01 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053326