Severe PneumoniaMASSNCT06114784
Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter, Cohort Study
An observational study of Severe Pneumonia, run by First Affiliated Hospital of Zhejiang University at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Pneumonia
- What is being tested?
- Metagenomics
- How many people
- 2,000 participants
- Where
- 15 sitesChina
- Study dates
- 25 Sep 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Expected length of stay in ICU is less than 1 day
- Pregnant
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Lingtong Huang, M.D., lingtonghuang@zju.edu.cn
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Gensheng Zhang, +8615150686177, genshengzhang@zju.edu.cn
Gensheng Zhang
- Recruiting
Shulan (Hangzhou) hospital
Hangzhou
Lingling Tang, M.D., lltang72@126.com
- Recruiting
Tongde Hospital of Zhejiang Province
Hangzhou
Muhua Dai, M.D., daimuhua8206@126.com
- Recruiting
the First People's Hospital of Huzhou
Huzhou
Kankai Tang, M.D., tkk790@163.com
- Recruiting
The First Hospital of Jiaxing
Jiaxing
Qianqian Wang, M.D., wangqianqian1101@126.com
- Recruiting
Lanxi Hospital of Traditional Chinese Medicine
Lanxi
Yonghui Xiong, M.D., xiongyonghui1986@126.com
- Recruiting
Lishui People's Hospital
Lishui
Xuwei He, M.D., x0301784@126.com
- Recruiting
The First People's Hospital of Pinghu
Pinghu
Lin Zhong, M.D., zhonglin9393@126.com
- Recruiting
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Taizhou
Yongpo Jiang, M.D., 7719@enzemed.com
- Recruiting
Wenzhou Central Hospital
Wenzhou
Xiaobo Wang, M.D., wxb49752403@163.com
- Recruiting
Xi'an People's Hospital (Xi'an No.4 Hospital)
Xi'an
Dan Dang, M.D., dangdan2005@163.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou
Mingqiang Wang, M.D., mingqiang_wang@163.com
- Recruiting
The Fifth Clinical Medical College of Henan University of Chinese Medicine
Zhengzhou
Hongyu Wang, M.D., hongyu260@163.com
- Recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou
Shengfeng Wang, M.D., wsfeng1011@163.com
About this study
Official title: Identification of Lung and Intestinal Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter Cohort Study
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.
Read the 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.
- Conditions
- Severe Pneumonia
- Being tested
- Metagenomics
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetagenomicsDiagnostic test
Clinical metagenomics is used to evaluate pathogens
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Metagenomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between lung microbiome and disease prognosis
- 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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start25 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe PneumoniaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingtong Huang, MD, First Affiliated Hospital of Zhejiang University
- Investigators
- Lingtong Huang, M.D., Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114784
- Sponsor's protocol ID
- IIT20230371B
- Acronym
- MASS
- Status last verified
- Aug 2025
- First submitted
- 24 Oct 2023
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Under the permission of Chinese law, if a researcher needs an IPD, the investigators can share the IPD.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Lung and Intestinal Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT06114784
- Acronym / sponsor ID
- MASS / IIT20230371B
- Conditions
- Severe Pneumonia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe pneumonia | – | Diagnostic Test: MetagenomicsDefinition 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Expected length of stay in ICU is less than 1 day
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetagenomicsClinical metagenomics is used to evaluate pathogens | Diagnostic test | Severe pneumonia |
Primary outcome
The correlation between lung microbiome and disease prognosis
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Undecided. Under the permission of Chinese law, if a researcher needs an IPD, the investigators can share the IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lingtong Huang, M.D. principal investigator
First Affiliated Hospital of Zhejiang University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Pneumonia, run by First Affiliated Hospital of Zhejiang University at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingtong Huang, M.D. (0571-87236309, lingtonghuang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between lung microbiome and disease prognosis (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.