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Clinical Trials/NCT06114784
NCT06114784
Recruiting
Not Applicable

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

First Affiliated Hospital of Zhejiang University15 sites in 1 country2,000 target enrollmentSeptember 25, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Pneumonia
Sponsor
First Affiliated Hospital of Zhejiang University
Enrollment
2000
Locations
15
Primary Endpoint
The correlation between lung microbiome and disease prognosis
Status
Recruiting
Last Updated
8 months ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 25, 2023
End Date
December 31, 2026
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Responsible Party
Principal Investigator
Principal Investigator

Lingtong Huang, MD

Doctor

First Affiliated Hospital of Zhejiang University

Eligibility Criteria

Inclusion Criteria

  • 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

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

Outcomes

Primary Outcomes

The correlation between lung microbiome and disease prognosis

Time Frame: 60 days

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.

Study Sites (15)

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