Microbe-host Interaction Relationship in Patients With Stroke-relatedPneumonia

Not yet recruiting

• Conditions: Stroke-related Pneumonia

• Registration Number: NCT06161298
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Brief 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.

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 Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Study First Posted: 2023-12-07
• Last Update Posted: 2023-12-07
• Study Start: 2023-12-20
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the microbiota in throat swabs and sputum	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.

Secondary Outcome Measures

Name	Time	Method
Utility-weighted modified Rankin scale score	90 days after enrollment	Utility-weighted modified Rankin scale score. Values range from 0 to 10: The higher the score, the better the result.
Barthel-Index (BI)	90 days after enrollment	BI values range from 0-100: The higher the score, the better the result.
Changes in the blood plasma metabolites	baseline, 3 days, 7 days, 14 days after enrollment, or at discharge	Ultra HPLC-tandem mass spectrometry will be used to test plasma metabolite expression in each group.
The European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)	90 days after enrollment	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.