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

Sepsis Clinical Trial

— DISPLAY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05612893
• Other study ID #: 2021-I2M-1-048
• Status: Not yet recruiting
• Start date: November 16, 2022
• Est. completion date: September 10, 2025

Study information

• Verified date: November 2022
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 10, 2025
• Est. primary completion date: April 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Influenza
• Pneumonia, Viral
• Respiratory Tract Infections
• Sepsis
• Toxemia
• Upper Respiratory Tract Infection
• Viral Pneumonia

Intervention

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.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	upper respiratory infection or pneumonia or Sepsis	Patients were grouped and compared according to their diagnosis.	up to 28 days
Secondary	Clinical status	assessed by Sequential Organ Failure Assessment	days 0, 3, 7
Secondary	All cause mortality		up to 28 days
Secondary	Length of hospital stay (days)		up to 28 days
Secondary	Length of ICU stay (days)		up to 28 days