Understanding the role of microbiomes in severe pneumonia

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

This study is trying to see how the bacteria in the lungs and gut affect how people with severe pneumonia get sick and recover.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Locations: 15 sites (Hangzhou, Zhejiang and 14 other locations)
• Trial ID: NCT06114784 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the relationship between lung and intestinal microbiomes and host susceptibility in patients with severe pneumonia. By collecting clinical samples such as sputum, alveolar lavage fluid, feces, and whole blood from ICU patients, the study seeks to clarify how these microbiomes influence disease progression and prognosis. The research will be conducted across multiple centers from 2023 to 2025, addressing the limitations of previous studies that were often small and single-centered.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with new lung infections requiring mechanical ventilation or high-flow oxygen therapy due to acute respiratory failure.

Not a fit: Patients expected to stay in the ICU for less than one day or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of severe pneumonia, potentially enhancing patient outcomes.

How similar studies have performed: While there have been small, single-center studies on this topic, this multicenter approach is novel and aims to provide more comprehensive insights.

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

Where this trial is running

Hangzhou, Zhejiang and 14 other locations

• First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Shulan (Hangzhou) hospital — Hangzhou, China (Recruiting)
• Tongde Hospital of Zhejiang Province — Hangzhou, China (Recruiting)
• the First People's Hospital of Huzhou — Huzhou, China (Recruiting)
• The First Hospital of Jiaxing — Jiaxing, China (Recruiting)
• Lanxi Hospital of Traditional Chinese Medicine — Lanxi, China (Recruiting)
• Lishui People's Hospital — Lishui, China (Recruiting)
• The First People's Hospital of Pinghu — Pinghu, China (Recruiting)
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University — Taizhou, China (Recruiting)
• Wenzhou Central Hospital — Wenzhou, China (Recruiting)
• Xi'an People's Hospital (Xi'an No.4 Hospital) — Xi'an, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, China (Recruiting)
• The Fifth Clinical Medical College of Henan University of Chinese Medicine — Zhengzhou, China (Recruiting)
• The Second Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)

Study contacts

• Principal investigator: Lingtong Huang, M.D. — Zhejiang University
• Study coordinator: Lingtong Huang, M.D.

Conditions Severe Pneumonia