SepsisDISPLAYNCT05612893
Discover the Immune Signature of Sepsis Caused by Acute Pulmonary Infection: A Cohort Study
An observational study of Sepsis and Viral Pneumonia, run by Capital Medical University at 1 site in China.
Trial summary
The goal of this observational study is to describe the immune signature of acute pulmonary infection.The main questions it aims to answer are: 1. Nasal mucosal immune response in patients with influenza infection 2. Difference of immune response between Viral sepsis and Bacterial sepsis 3. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Viral Pneumonia, Influenza
- What is being tested?
- pathogen
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2022to 10 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are diagnosed pneumonia and signed informed consent will be enrolled.
Who may be able to join
- Age ≥18 years at time of signing Informed Consent Form
- chest imaging confirmed pneumonia.
- Informed consent is obtained
- The pneumonia onset ≤8 days
Who cannot join
- SaO2/SPO2≤94% on room air or Pa02/Fi02 ratio <300mgHg before the onset of pneumonia
- Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)
- Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis,peritoneal dialysis）
- Pregnant Or Lactating Women
- Patients were eligible for organ transplantation or had undergone previous organ transplantation surgery
- HIV infection
- Had unstable angina or myocardial infarction within 30 days without vascular recanalization treatment
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Bin Cao, Professor, 86-010-84206264, caobin_ben@163.com
About this study
The goal of this observational study is to describe the immune signature of acute pulmonary infection.The main questions it aims to answer are:
- Nasal mucosal immune response in patients with influenza infection
- Difference of immune response between Viral sepsis and Bacterial sepsis
- Immunological differences between Viral sepsis and Viral pneumonia
Read the detailed description
- Aging could influence host immune response. Elderly people are more likely to progress to severe pneumonia than young people. Nasal mucosa is the initial infection site of influenza infection. Single cell sequencing of nasal mucosal cell that may provide valuable insights into host response to influenza infection.
- Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Although bacteria are considered as the main pathgens of sepsis，SARS-CoV-2 or influenza infection also can cause multiple organ dysfunction which meet the definition of Sepsis 3.0. Viral sepsis has not received enough attention for a long time. It is important to understand the difference between viral sepsis and bacterial sepsis that may help to develop better strategies to diagnose and treat sepsis.
- Viral pneumonia is one of the leading infectious cause of death woldwide.Pneumina is the most common cause of sepsis.The mechanism of viral pneumonia progressing to sepsis needs to be further investigated.
- Conditions
- Sepsis, Viral Pneumonia, Influenza, Upper Respiratory Tract Infection
- Being tested
- pathogen
- Medical subject headings
- Sepsis, Pneumonia, Viral, Influenza, Human, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pathogenOther
Also called age
The patients were divided into groups according to the pathogen(bacteria or virus).
The influenza upper respiratory tract infection cohort will be grouped mainly according to age.
| Study group | Role | What they receive |
|---|---|---|
| Influenza upper respiratory infection | This cohort aims to descirbe the nasal mucosal immune response in influenza patients. We will collect nasal mucosal cells from influenza patients using Nasal Cytology Curettes. Blood samples will also be obtained from the patient. All samples will be used for single cell sequencing. Receives: Other: pathogen | |
| Viral Sepsis and Viral pneumonia | The purpose of this cohort is to characterize the immune pattern of patients with viral sepsis and find specific target for the treatment of viral sepsis. Blood samples will be obtained from the viral sepsis/pneumonia patients.All samples will be used for transcriptome sequencing. Receives: Other: pathogen | |
| Bacterial Sepsis and Bacterial pneumonia | This cohort served as a control for the viral sepsis/pneumonia cohort.Blood samples will be obtained from the bacterial sepsis/pneumonia patients.All samples will be used for transcriptome sequencing. Receives: Other: pathogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper respiratory infection or pneumonia or Sepsis
Patients were grouped and compared according to their diagnosis.
Measured: up to 28 days
Secondary outcomes (4)
Clinical status
assessed by Sequential Organ Failure Assessment
Measured: days 0, 3, 7
All cause mortality
Measured: up to 28 days
Length of hospital stay (days)
Measured: up to 28 days
Length of ICU stay (days)
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start16 Nov 2022 (estimated)
- Primary completion10 Apr 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Capital Medical 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612893
- Sponsor's protocol ID
- 2021-I2M-1-048
- Acronym
- DISPLAY
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the transcriptome data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discover the Immune Signature of Sepsis Caused by Acute Pulmonary Infection: A Cohort Study
- ClinicalTrials.gov ID
- NCT05612893
- Acronym / sponsor ID
- DISPLAY / 2021-I2M-1-048
- Conditions
- Sepsis, Viral Pneumonia, Influenza, Upper Respiratory Tract Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 16 Nov 2022 (estimated)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 10 Nov 2022 (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.
The goal of this observational study is to describe the immune signature of acute pulmonary infection.The main questions it aims to answer are:
- Nasal mucosal immune response in patients with influenza infection
- Difference of immune response between Viral sepsis and Bacterial sepsis
- Immunological differences between Viral sepsis and Viral pneumonia
Detailed description
- Aging could influence host immune response. Elderly people are more likely to progress to severe pneumonia than young people. Nasal mucosa is the initial infection site of influenza infection. Single cell sequencing of nasal mucosal cell that may provide valuable insights into host response to influenza infection.
- Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Although bacteria are considered as the main pathgens of sepsis，SARS-CoV-2 or influenza infection also can cause multiple organ dysfunction which meet the definition of Sepsis 3.0. Viral sepsis has not received enough attention for a long time. It is important to understand the difference between viral sepsis and bacterial sepsis that may help to develop better strategies to diagnose and treat sepsis.
- Viral pneumonia is one of the leading infectious cause of death woldwide.Pneumina is the most common cause of sepsis.The mechanism of viral pneumonia progressing to sepsis needs to be further investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Influenza upper respiratory infection | – | Other: pathogenThis cohort aims to descirbe the nasal mucosal immune response in influenza patients. We will collect nasal mucosal cells from influenza patients using Nasal Cytology Curettes. Blood samples will also be obtained from the patient. All samples will be used for single cell sequencing. |
| Viral Sepsis and Viral pneumonia | – | Other: pathogenThe purpose of this cohort is to characterize the immune pattern of patients with viral sepsis and find specific target for the treatment of viral sepsis. Blood samples will be obtained from the viral sepsis/pneumonia patients.All samples will be used for transcriptome sequencing. |
| Bacterial Sepsis and Bacterial pneumonia | – | Other: pathogenThis cohort served as a control for the viral sepsis/pneumonia cohort.Blood samples will be obtained from the bacterial sepsis/pneumonia patients.All samples will be used for transcriptome sequencing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed pneumonia and signed informed consent will be enrolled.
Key inclusion criteria (4 listed)
- Age ≥18 years at time of signing Informed Consent Form
- chest imaging confirmed pneumonia.
- Informed consent is obtained
- The pneumonia onset ≤8 days
Key exclusion criteria (7 listed)
- SaO2/SPO2≤94% on room air or Pa02/Fi02 ratio <300mgHg before the onset of pneumonia
- Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)
- Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis,peritoneal dialysis）
- Pregnant Or Lactating Women
- Patients were eligible for organ transplantation or had undergone previous organ transplantation surgery
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 |
|---|---|---|
| pathogenAlso: ageThe patients were divided into groups according to the pathogen(bacteria or virus). The influenza upper respiratory tract infection cohort will be grouped mainly according to age. | Other | Bacterial Sepsis and Bacterial pneumonia, Influenza upper respiratory infection, Viral Sepsis and Viral pneumonia |
Primary outcome
upper respiratory infection or pneumonia or Sepsis
Time frame: up to 28 days
Patients were grouped and compared according to their diagnosis.
4 secondary outcomes
Clinical status
Time frame: days 0, 3, 7
All cause mortality
Time frame: up to 28 days
Length of hospital stay (days)
Time frame: up to 28 days
Length of ICU stay (days)
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: Yes. We will share the transcriptome data with other researchers.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Viral Pneumonia, run by Capital Medical University at 1 site 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper respiratory infection or pneumonia or Sepsis (time frame: up to 28 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 10 Nov 2022.