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

NCT ID: NCT05612893

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2025-09-10

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

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.

Conditions

Sepsis; Viral Pneumonia; Influenza; Upper Respiratory Tract Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

pathogen

Intervention Type: OTHER

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.

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.

pathogen

Intervention Type: OTHER

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.

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.

pathogen

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

age

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Bin Cao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

Facility Contacts

Bin Cao, Professor

Role: primary

caobin_ben@163.com

86-010-84206264

Other Identifiers

2021-I2M-1-048

Identifier Type: -

Identifier Source: org_study_id