NCT06114784

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Sep 2023Dec 2026

Study Start

First participant enrolled

September 25, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

3.3 years

First QC Date

October 24, 2023

Last Update Submit

August 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The correlation between lung microbiome and disease prognosis

    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.

    60 days

Study Arms (1)

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.

Diagnostic Test: Metagenomics

Interventions

MetagenomicsDIAGNOSTIC_TEST

Clinical metagenomics is used to evaluate pathogens

Severe pneumonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \. 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, 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

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage fluid, sputum, feces, peripheral blood

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lingtong Huang, M.D.

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingtong Huang, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 24, 2023

First Posted

November 2, 2023

Study Start

September 25, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08

Locations