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

Zhejiang University

Status: Enrolling

Conditions: Severe Pneumonia

Treatments: Diagnostic Test: Metagenomics

Study type: Observational

Funder types: Other

Identifiers

NCT06114784

IIT20230371B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

Severe pneumonia

Description:

Definition of severe pneumonia: New 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; The patient receives high flow oxygen therapy with a FiO2 of 50% or more and a PaO2: FiO2 ratio of less than 300; The patient receives oxygen treatment with a partial respiration mask with an air storage bag, provided that PaO2 is lower than the pre-specified indicator.

Treatment:

Diagnostic Test: Metagenomics