Clinical trial NCT06161298: Microbe-host Interaction Relationship in Patients With Stroke-relatedPneumonia
Official title: Microbe-host Interaction Relationship in Patients With Stroke-related Pneumonia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke-related Pneumonia
Keywords: Stroke-related pneumonia
micropopulation
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the microbiota in throat swabs and sputum
timeFrame: baseline, 3 days, 7 days, 14 days after enrollment, or at discharge
Secondary outcomes:
measure: Utility-weighted modified Rankin scale score
timeFrame: 90 days after enrollment
measure: The European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)
timeFrame: 90 days after enrollment
measure: Barthel-Index (BI)
timeFrame: 90 days after enrollment
measure: Changes in the blood plasma metabolites
timeFrame: baseline, 3 days, 7 days, 14 days after enrollment, or at discharge
Other outcomes:
Locations:
Study officials:
affiliation: Guangdong Province Hospital of Tradtional Chinese Medicine
name: Jianwen Guo, Dr
role: STUDY_DIRECTOR
References: