Stroke-related PneumoniaNCT06161298
Microbe-host Interaction Relationship in Patients With Stroke-relatedPneumonia
An observational study of Stroke-related Pneumonia, run by Guangzhou University of Traditional Chinese Medicine.
Trial summary
This study intends to use a standardized cohort study to collect biological samples (including throat swabs, sputum and blood) from subjects eligible for inclusion, and use 16s DNA / metagenomic sequencing and metabolome technology to explore the microbial-host interaction relationship of SAP patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke-related Pneumonia
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 30 Jun 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: From December 2023 to December 2024, patients with new stroke at Guangdong Hospital of Traditional Chinese Medicine will be this study population. All eligible participants will be followed up for 90 days.
Who may be able to join
- Age: 18 years old;
- Stroke was confirmed by imaging;
- Within 48 hours of onset, the onset time cannot be determined from the last normal observation;
- Glasgow Coma Scale (GCS) 7-14;
- SAP by clinical symptoms, laboratory examination or imaging confirmation, the modified CDC diagnostic criteria;
- The patient (or his / her legal representative) signs a written informed consent form.
Who cannot join
- Use of antibiotics within 4 weeks before stroke onset;
- The presence of other conditions that may interfere with the follow-up and outcome assessment (such as known significant prestroke disability, mRS score of 3-5, end-stage malignancy, and liver and renal failure);
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Microbe-host Interaction Relationship in Patients With Stroke-related Pneumonia
This study intends to use a standardized cohort study to collect biological samples (including throat swabs, sputum and blood) from subjects eligible for inclusion, and use 16s DNA / metagenomic sequencing and metabolome technology to explore the microbial-host interaction relationship of SAP patients.
Read the detailed description
Stroke-related pneumonia (SAP) is the most common complication of acute cerebral hemorrhage, and it is one of the main causes of disease aggravation, prolonged hospitalization and costs, and even death. The traditional antibiotic model proved ineffective, and new prevention and treatment methods were urgently sought.This study intends to use a standardized and rigorous cohort study to collect biological samples (including throat swabs, sputum and blood) of eligible subjects, and to explore the microbial-host interaction relationship in patients with SAP, which may provide new targets and new ideas for the prevention and control of SAP.
- Conditions
- Stroke-related Pneumonia
- Keywords
- Stroke-related pneumonia, micropopulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | age> 18, without lung disease | |
| NSAP group | patients with no stroke pneumonia | |
| SAP group | Those diagnosed with stroke-related pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the microbiota in throat swabs and sputum
Microbiota changes in each set of throat swabs and sputum will be examined using 16s DNA / metagenome sequencing.
Measured: baseline, 3 days, 7 days, 14 days after enrollment, or at discharge
Secondary outcomes (4)
Utility-weighted modified Rankin scale score
Utility-weighted modified Rankin scale score. Values range from 0 to 10: The higher the score, the better the result.
Measured: 90 days after enrollment
The European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
The EQ-5D includes five dimensions of health: mobility, self-care, ability to perform daily activities, pain and discomfort, and anxiety and depression. EQ-5D-5L, including five severity levels (none, minor, moderate, severe, serious, and extreme). Value range 0-100: The higher the score, the worse the result.
Measured: 90 days after enrollment
Barthel-Index (BI)
BI values range from 0-100: The higher the score, the better the result.
Measured: 90 days after enrollment
Changes in the blood plasma metabolites
Ultra HPLC-tandem mass spectrometry will be used to test plasma metabolite expression in each group.
Measured: baseline, 3 days, 7 days, 14 days after enrollment, or at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke-related PneumoniaStudies of the same condition, open and under way.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianwen Guo, Dr, Study director, Guangdong Province Hospital of Tradtional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161298
- Sponsor's protocol ID
- SAP20231201
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbe-host Interaction Relationship in Patients With Stroke-related Pneumonia
- ClinicalTrials.gov ID
- NCT06161298
- Acronym / sponsor ID
- SAP20231201
- Conditions
- Stroke-related Pneumonia
- Keywords
- Stroke-related pneumonia, micropopulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 7 Dec 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 intends to use a standardized cohort study to collect biological samples (including throat swabs, sputum and blood) from subjects eligible for inclusion, and use 16s DNA / metagenomic sequencing and metabolome technology to explore the microbial-host interaction relationship of SAP patients.
Detailed description
Stroke-related pneumonia (SAP) is the most common complication of acute cerebral hemorrhage, and it is one of the main causes of disease aggravation, prolonged hospitalization and costs, and even death. The traditional antibiotic model proved ineffective, and new prevention and treatment methods were urgently sought.This study intends to use a standardized and rigorous cohort study to collect biological samples (including throat swabs, sputum and blood) of eligible subjects, and to explore the microbial-host interaction relationship in patients with SAP, which may provide new targets and new ideas for the prevention and control of SAP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | – | –age> 18, without lung disease |
| NSAP group | – | –patients with no stroke pneumonia |
| SAP group | – | –Those diagnosed with stroke-related pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From December 2023 to December 2024, patients with new stroke at Guangdong Hospital of Traditional Chinese Medicine will be this study population. All eligible participants will be followed up for 90 days.
Key inclusion criteria (6 listed)
- Age: 18 years old;
- Stroke was confirmed by imaging;
- Within 48 hours of onset, the onset time cannot be determined from the last normal observation;
- Glasgow Coma Scale (GCS) 7-14;
- SAP by clinical symptoms, laboratory examination or imaging confirmation, the modified CDC diagnostic criteria;
Key exclusion criteria (3 listed)
- Use of antibiotics within 4 weeks before stroke onset;
- The presence of other conditions that may interfere with the follow-up and outcome assessment (such as known significant prestroke disability, mRS score of 3-5, end-stage malignancy, and liver and renal failure);
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in the microbiota in throat swabs and sputum
Time frame: baseline, 3 days, 7 days, 14 days after enrollment, or at discharge
Microbiota changes in each set of throat swabs and sputum will be examined using 16s DNA / metagenome sequencing.
4 secondary outcomes
Utility-weighted modified Rankin scale score
Time frame: 90 days after enrollment
The European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
Time frame: 90 days after enrollment
Barthel-Index (BI)
Time frame: 90 days after enrollment
Changes in the blood plasma metabolites
Time frame: baseline, 3 days, 7 days, 14 days after enrollment, or at discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke-related Pneumonia
Not yet recruitingObservational study
Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
Post-stroke Pneumonia
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.
Jianwen Guo, Dr study director
Guangdong Province Hospital of Tradtional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke-related Pneumonia, run by Guangzhou University of Traditional Chinese Medicine.
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 6 inclusion and 3 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 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jianwen Guo, Dr (13724899379, 306247680@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the microbiota in throat swabs and sputum (time frame: baseline, 3 days, 7 days, 14 days after enrollment, or at discharge). 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 Dec 2023.