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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06114784
Acronym
MASS
Enrollment
2000
Registered
2023-11-02
Start date
2023-09-25
Completion date
2026-12-31
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Pneumonia

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.

Interventions

DIAGNOSTIC_TESTMetagenomics

Clinical metagenomics is used to evaluate pathogens

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The correlation between lung microbiome and disease prognosis60 days1\. 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.

Countries

China

Contacts

Primary ContactLingtong Huang, M.D.
lingtonghuang@zju.edu.cn0571-87236309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026