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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05612893
Other study ID # 2021-I2M-1-048
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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