Clinical trial NCT06114784: Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter, Cohort Study
Official title: Identification of Lung and Intestinal Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Pneumonia
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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:

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

Primary outcomes:
measure: The correlation between lung microbiome and disease prognosis
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Shulan (Hangzhou) hospital
city: Hangzhou
country: China
facility: Tongde Hospital of Zhejiang Province
city: Huzhou
country: China
facility: the First People's Hospital of Huzhou
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
city: Lanxi
country: China
facility: Lanxi Hospital of Traditional Chinese Medicine
city: Lishui
country: China
facility: Lishui People's Hospital
city: Pinghu
country: China
facility: The First People's Hospital of Pinghu
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
city: Wenzhou
country: China
facility: Wenzhou Central Hospital
city: Xi'an
country: China
facility: Xi'an People's Hospital (Xi'an No.4 Hospital)
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zhengzhou
country: China
facility: The Fifth Clinical Medical College of Henan University of Chinese Medicine
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Zhejiang University
name: Lingtong Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: