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

August 4, 2025 updated by: Lingtong Huang, MD, First Affiliated Hospital of Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hangzhou, China
        • Recruiting
        • Shulan (Hangzhou) Hospital
        • Contact:
      • Hangzhou, China
        • Recruiting
        • Tongde Hospital of Zhejiang Province
        • Contact:
      • Huzhou, China
        • Recruiting
        • The First People's Hospital of Huzhou
        • Contact:
      • Jiaxing, China
      • Lanxi, China
        • Recruiting
        • Lanxi Hospital of Traditional Chinese Medicine
        • Contact:
      • Lishui, China
        • Recruiting
        • Lishui People's Hospital
        • Contact:
      • Pinghu, China
        • Recruiting
        • The First People's Hospital of Pinghu
        • Contact:
      • Taizhou, China
        • Recruiting
        • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
        • Contact:
      • Wenzhou, China
      • Xi'an, China
        • Recruiting
        • Xi'an People's Hospital (Xi'an No.4 Hospital)
        • Contact:
      • Zhengzhou, China
      • Zhengzhou, China
        • Recruiting
        • The Fifth Clinical Medical College of Henan University of Chinese Medicine
        • Contact:
      • Zhengzhou, China
        • Recruiting
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
        • Sub-Investigator:
          • Gensheng Zhang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Overall, the investigators will include all severe pneumonia patients transferred to the ICU, including community acquired pneumonia, hospital acquired pneumonia, and ventilator-associated pneumonia.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Severe pneumonia
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.
Diagnostic test: Metagenomics
Clinical metagenomics is used to evaluate pathogens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Investigators

  • Principal Investigator: Lingtong Huang, M.D., Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 28, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20230371B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Under the permission of Chinese law, if a researcher needs an IPD, the investigators can share the IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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