Microbe-host Interaction Relationship in Patients With Stroke-relatedPneumonia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Microbe-host Interaction Relationship in Patients With Stroke-related Pneumonia

Conditions
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Stroke-related Pneumonia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy control group<br>age> 18, without lung disease | |
| NSAP group<br>patients with no stroke pneumonia | |
| SAP group<br>Those diagnosed with stroke-related pneumonia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 3 days, 7 days, 14 days after enrollment, or at discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 90 days after enrollment | 
| Barthel-Index (BI) | BI values range from 0-100: The higher the score, the better the result. | 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. | baseline, 3 days, 7 days, 14 days after enrollment, or at discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke-related pneumonia, micropopulation