Microbe-host Interaction Relationship in Patients With Stroke-relatedPneumonia

Guangzhou University of Traditional Chinese Medicine240 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

240

Conditions

Stroke-related Pneumonia

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: baseline, 3 days, 7 days, 14 days after enrollment, or at discharge

Secondary Outcomes

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.

Time frame: 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.

Time frame: 90 days after enrollment

Barthel-Index (BI)

BI values range from 0-100: The higher the score, the better the result.

Time frame: 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.

Time frame: baseline, 3 days, 7 days, 14 days after enrollment, or at discharge

Central Contacts

Jianwen Guo, Dr

CONTACT

13724899379 306247680@qq.com

Dou Wang, Dr

CONTACT

18292998840 wd18292998840@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.