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

NCT05612893 | Unknown

• 1 other identifier: 2021-I2M-1-048
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. 1.Nasal mucosal immune response in patients with influenza infection
2. 2.Difference of immune response between Viral sepsis and Bacterial sepsis
3. 3.Immunological differences between Viral sepsis and Viral pneumonia

Conditions

Sepsis; Viral Pneumonia; Influenza; Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• upper respiratory infection or pneumonia or Sepsis

  Patients were grouped and compared according to their diagnosis.

  up to 28 days

Secondary Outcomes (4)

• Clinical status

  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

Study Arms (3)

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

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

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

Interventions

pathogen 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.

Also known as: age

Bacterial Sepsis and Bacterial pneumonia; Influenza upper respiratory infection; Viral Sepsis and Viral pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age ≥18 years at time of signing Informed Consent Form
• chest imaging confirmed pneumonia.
• Informed consent is obtained
• The pneumonia onset ≤8 days

You may not qualify if:

• SaO2/SPO2≤94% on room air or Pa02/Fi02 ratio \<300mgHg before the onset of pneumonia
• Severe liver disease (e.g. Child Pugh score ≥ C, AST\>5 times upper limit)
• 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）
• Pregnant Or Lactating Women
• Patients were eligible for organ transplantation or had undergone previous organ transplantation surgery
• HIV infection
• Had unstable angina or myocardial infarction within 30 days without vascular recanalization treatment

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood was collected by the hospital nurse. Nasal mucosal cells will be obtained by Nasal Cytology Curettes.

MeSH Terms

Conditions

Sepsis; Pneumonia, Viral; Influenza, Human; Respiratory Tract Infections

Interventions

Aging

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 10, 2022
• Study Start: November 16, 2022
• Primary Completion: April 10, 2025
• Study Completion: September 10, 2025
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE

Locations

CN (1)