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

Not yet recruiting

• Conditions: Sepsis; Upper Respiratory Tract Infection; Viral Pneumonia; Influenza
• Interventions: Other: pathogen

• Registration Number: NCT05612893
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-08
• Last Update Submitted: 2022-11-08
• Study First Posted: 2022-11-10
• Last Update Posted: 2022-11-10
• Study Start: 2022-11-16
• Primary Completion: 2025-04-10
• Study Completion: 2025-09-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Influenza upper respiratory infection	pathogen	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.
Viral Sepsis and Viral pneumonia	pathogen	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.
Bacterial Sepsis and Bacterial pneumonia	pathogen	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.

Primary Outcome Measures

Name	Time	Method
upper respiratory infection or pneumonia or Sepsis	up to 28 days	Patients were grouped and compared according to their diagnosis.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China