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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Influenza; Upper Respiratory Tract Infection; Viral Pneumonia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
      • Contact: Bin Cao, Professor; Phone Number: 86-010-84206264; Email: caobin_ben@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are diagnosed pneumonia and signed informed consent will be enrolled.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
upper respiratory infection or pneumonia or Sepsis	Patients were grouped and compared according to their diagnosis.	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical status	assessed by Sequential Organ Failure Assessment	days 0, 3, 7
All cause mortality		up to 28 days
Length of hospital stay (days)		up to 28 days
Length of ICU stay (days)		up to 28 days

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 16, 2022
• Primary Completion (Anticipated): April 10, 2025
• Study Completion (Anticipated): September 10, 2025

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Infections; Communicable Diseases; Pneumonia, Viral; Respiratory Tract Infections
• Other Study ID Numbers: 2021-I2M-1-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We will share the transcriptome data with other researchers.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No