UMIN-CTR Clinical Trial

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

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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 or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053326