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

NCT ID: NCT06114784

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-25

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Metagenomics

Intervention Type DIAGNOSTIC_TEST

Clinical metagenomics is used to evaluate pathogens

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metagenomics

Clinical metagenomics is used to evaluate pathogens

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lingtong Huang, MD

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lingtong Huang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Shulan (Hangzhou) hospital

Hangzhou, , China

Site Status RECRUITING

Tongde Hospital of Zhejiang Province

Hangzhou, , China

Site Status RECRUITING

the First People's Hospital of Huzhou

Huzhou, , China

Site Status RECRUITING

The First Hospital of Jiaxing

Jiaxing, , China

Site Status RECRUITING

Lanxi Hospital of Traditional Chinese Medicine

Lanxi, , China

Site Status RECRUITING

Lishui People's Hospital

Lishui, , China

Site Status RECRUITING

The First People's Hospital of Pinghu

Pinghu, , China

Site Status RECRUITING

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Taizhou, , China

Site Status RECRUITING

Wenzhou Central Hospital

Wenzhou, , China

Site Status RECRUITING

Xi'an People's Hospital (Xi'an No.4 Hospital)

Xi'an, , China

Site Status RECRUITING

Henan Provincial People's Hospital

Zhengzhou, , China

Site Status RECRUITING

The Fifth Clinical Medical College of Henan University of Chinese Medicine

Zhengzhou, , China

Site Status RECRUITING

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lingtong Huang, M.D.

Role: CONTACT

0571-87236309

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lingtong Huang, M.D.

Role: primary

Gensheng Zhang

Role: primary

+8615150686177

Lingling Tang, M.D.

Role: primary

Muhua Dai, M.D.

Role: primary

Kankai Tang, M.D.

Role: primary

Qianqian Wang, M.D.

Role: primary

Yonghui Xiong, M.D.

Role: primary

Xuwei He, M.D.

Role: primary

Lin Zhong, M.D.

Role: primary

Yongpo Jiang, M.D.

Role: primary

Xiaobo Wang, M.D.

Role: primary

Dan Dang, M.D.

Role: primary

Mingqiang Wang, M.D.

Role: primary

Hongyu Wang, M.D.

Role: primary

Shengfeng Wang, M.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIT20230371B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.