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Recruiting NCT06114784

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

Observational Severe Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metagenomics.
Who it may be relevant to
Registry conditions: Severe Pneumonia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 test Metagenomics
    Clinical metagenomics is used to evaluate pathogens

Primary outcome measures

  • The correlation between lung microbiome and disease prognosis [Time frame: 60 days]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 15 centers
  • First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
  • The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
  • Shulan (Hangzhou) hospital — Hangzhou
  • Tongde Hospital of Zhejiang Province — Hangzhou
  • the First People's Hospital of Huzhou — Huzhou
  • The First Hospital of Jiaxing — Jiaxing
  • Lanxi Hospital of Traditional Chinese Medicine — Lanxi
  • Lishui People's Hospital — Lishui
  • … and 7 more centers

Identifiers

NCT: NCT06114784 · IIT20230371B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗