Microbe-host Interaction Relationship in Patients With Stroke-relatedPneumonia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke-related Pneumonia

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 Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Jianwen Guo, Dr; Phone Number: 13724899379; Email: 306247680@qq.com
• Study Contact Backup: Name: Dou Wang, Dr; Phone Number: 18292998840; Email: wd18292998840@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Investigators: Study Director: Jianwen Guo, Dr, Guangdong Province Hospital of Tradtional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Stroke-related pneumonia; micropopulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Stroke; Pneumonia
• Other Study ID Numbers: SAP20231201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No