Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter, Cohort Study
- Conditions
- Severe Pneumonia
- Interventions
- Diagnostic Test: metagenomics
- Registration Number
- NCT06114784
- Lead Sponsor
- First Affiliated Hospital of Zhejiang University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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
- Expected length of stay in ICU is less than 1 day
- Pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Severe pneumonia metagenomics 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.
- Primary Outcome Measures
Name Time Method The correlation between lung microbiome and disease prognosis 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
First Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Shulan (Hangzhou) hospital
🇨🇳Hangzhou, China
Tongde Hospital of Zhejiang Province
🇨🇳Hangzhou, China
the First People's Hospital of Huzhou
🇨🇳Huzhou, China
The First Hospital of Jiaxing
🇨🇳Jiaxing, China
Lanxi Hospital of Traditional Chinese Medicine
🇨🇳Lanxi, China
Lishui People's Hospital
🇨🇳Lishui, China
The First People's Hospital of Pinghu
🇨🇳Pinghu, China
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
🇨🇳Taizhou, China
Wenzhou Central Hospital
🇨🇳Wenzhou, China
Xi'an People's Hospital (Xi'an No.4 Hospital)
🇨🇳Xi'an, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China
The Fifth Clinical Medical College of Henan University of Chinese Medicine
🇨🇳Zhengzhou, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China