Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter, Cohort Study

Severe Pneumonia Clinical Trial

— MASS  

Official title:

Identification of Lung and Intestinal Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06114784
• Other study ID #: IIT20230371B
• Status: Recruiting
• Start date: September 25, 2023
• Est. completion date: September 25, 2024

Study information

• Verified date: February 2024
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Lingtong Huang, MD
• Phone: 0571-87236309
• Email: lingtonghuang[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study was a prospective multicenter cohort of severe pneumonia. And by collecting clinical samples to clarify the correlation between lung microbiome, intestinal microbiome, host susceptibility, and prognosis of severe pneumonia patients.

Description:

The human lung and intestinal microbiota play an important role in human health. At present, the correlation between lung and intestinal microbiota in severe pneumonia patients and host susceptibility is limited to small sample, single center studies. Due to sample size limitations, the pathogenesis of severe pneumonia caused by many pathogens remains unclear. This study plans to construct sputum, alveolar lavage fluid, feces, and whole blood samples of severe pneumonia patients admitted to the ICU from 2023 to 2025, and collect clinical data from patients to identify changes in lung and intestinal microbiome, host susceptibility, and disease progression risk in different groups of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 25, 2024
• Est. primary completion date: September 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. New lung infection that meets one of the following definitions: the patient receives mechanical ventilation (invasive or non-invasive) due to acute respiratory failure, with a PEEP level of 5cm or above; Patients receiving high flow oxygen therapy with a FiO2 of 50% or more and a PaO2: FiO2 ratio below 300

Exclusion Criteria:

1. Expected length of stay in ICU is less than 1 day

2. Pregnant

Related Conditions & MeSH terms

• Pneumonia
• Severe Pneumonia

Intervention

Diagnostic Test:
• metagenomics
Perform metagenomic analysis on balf, feces, and blood

Locations

Country	Name	City	State
China	First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Shulan (Hangzhou) hospital	Hangzhou
China	Tongde Hospital of Zhejiang Province	Hangzhou
China	The First Hospital of Jiaxing	Jiaxing
China	Pujiang County People's Hospital	Jinhua
China	Lanxi Hospital of Traditional Chinese Medicine	Lanxi
China	Lishui People's Hospital	Lishui
China	The First People's Hospital of Pinghu	Pinghu
China	Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University	Taizhou
China	Wenzhou Central Hospital	Wenzhou
China	Xi'an People's Hospital (Xi'an No.4 Hospital)	Xi'an
China	Henan Provincial People's Hospital	Zhengzhou
China	The Fifth Clinical Medical College of Henan University of Chinese Medicine	Zhengzhou
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation between lung microbiome and disease prognosis	1. Identification of microbial gene profiles; 2. Analysis of host health dynamics and trends; 3. Identification of host gene mutations; 4. Preliminary model construction; 5. Model optimization and evaluation.	60 days