DISPLAY: Discover the Immune Signature of Sepsis Caused by Acute Pulmonary Infection: A Cohort Study

Sponsor
Capital Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05612893
Collaborator
(none)
1,000
1
33.8
29.6

Study Details

Study Description

Brief Summary

The goal of this observational study is to describe the immune signature of acute pulmonary infection.The main questions it aims to answer are:

  1. Nasal mucosal immune response in patients with influenza infection

  2. Difference of immune response between Viral sepsis and Bacterial sepsis

  3. Immunological differences between Viral sepsis and Viral pneumonia

Condition or Disease Intervention/Treatment Phase
  • Other: pathogen

Detailed Description

  1. Aging could influence host immune response. Elderly people are more likely to progress to severe pneumonia than young people. Nasal mucosa is the initial infection site of influenza infection. Single cell sequencing of nasal mucosal cell that may provide valuable insights into host response to influenza infection.

  2. Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Although bacteria are considered as the main pathgens of sepsis,SARS-CoV-2 or influenza infection also can cause multiple organ dysfunction which meet the definition of Sepsis 3.0. Viral sepsis has not received enough attention for a long time. It is important to understand the difference between viral sepsis and bacterial sepsis that may help to develop better strategies to diagnose and treat sepsis.

  3. Viral pneumonia is one of the leading infectious cause of death woldwide.Pneumina is the most common cause of sepsis.The mechanism of viral pneumonia progressing to sepsis needs to be further investigated.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Discover the Immune Signature of Sepsis Caused by Acute Pulmonary Infection: A Cohort Study
Anticipated Study Start Date :
Nov 16, 2022
Anticipated Primary Completion Date :
Apr 10, 2025
Anticipated Study Completion Date :
Sep 10, 2025

Arms and Interventions

Arm Intervention/Treatment
Influenza upper respiratory infection

This cohort aims to descirbe the nasal mucosal immune response in influenza patients. We will collect nasal mucosal cells from influenza patients using Nasal Cytology Curettes. Blood samples will also be obtained from the patient. All samples will be used for single cell sequencing.

Other: pathogen
The patients were divided into groups according to the pathogen(bacteria or virus). The influenza upper respiratory tract infection cohort will be grouped mainly according to age.
Other Names:
  • age
  • Viral Sepsis and Viral pneumonia

    The purpose of this cohort is to characterize the immune pattern of patients with viral sepsis and find specific target for the treatment of viral sepsis. Blood samples will be obtained from the viral sepsis/pneumonia patients.All samples will be used for transcriptome sequencing.

    Other: pathogen
    The patients were divided into groups according to the pathogen(bacteria or virus). The influenza upper respiratory tract infection cohort will be grouped mainly according to age.
    Other Names:
  • age
  • Bacterial Sepsis and Bacterial pneumonia

    This cohort served as a control for the viral sepsis/pneumonia cohort.Blood samples will be obtained from the bacterial sepsis/pneumonia patients.All samples will be used for transcriptome sequencing.

    Other: pathogen
    The patients were divided into groups according to the pathogen(bacteria or virus). The influenza upper respiratory tract infection cohort will be grouped mainly according to age.
    Other Names:
  • age
  • Outcome Measures

    Primary Outcome Measures

    1. upper respiratory infection or pneumonia or Sepsis [up to 28 days]

      Patients were grouped and compared according to their diagnosis.

    Secondary Outcome Measures

    1. Clinical status [days 0, 3, 7]

      assessed by Sequential Organ Failure Assessment

    2. All cause mortality [up to 28 days]

    3. Length of hospital stay (days) [up to 28 days]

    4. Length of ICU stay (days) [up to 28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Age ≥18 years at time of signing Informed Consent Form

    2. chest imaging confirmed pneumonia.

    3. Informed consent is obtained

    4. The pneumonia onset ≤8 days

    Exclusion Criteria:
    1. SaO2/SPO2≤94% on room air or Pa02/Fi02 ratio <300mgHg before the onset of pneumonia

    2. Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)

    3. Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis,peritoneal dialysis)

    4. Pregnant Or Lactating Women

    5. Patients were eligible for organ transplantation or had undergone previous organ transplantation surgery

    6. HIV infection

    7. Had unstable angina or myocardial infarction within 30 days without vascular recanalization treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 China-Japan Friendship Hospital Beijing Beijing China 100029

    Sponsors and Collaborators

    • Capital Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bin Cao, Professor, Capital Medical University
    ClinicalTrials.gov Identifier:
    NCT05612893
    Other Study ID Numbers:
    • 2021-I2M-1-048
    First Posted:
    Nov 10, 2022
    Last Update Posted:
    Nov 10, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 10, 2022