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Microbe-host Interaction Relationship in Patients With Stroke-relatedPneumonia

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06161298
Enrollment
240
Registered
2023-12-07
Start date
2023-12-20
Completion date
2025-06-30
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke-related Pneumonia

Keywords

Stroke-related pneumonia, micropopulation

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.

Interventions

None listed

Sponsors

Guangzhou University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in the microbiota in throat swabs and sputumbaseline, 3 days, 7 days, 14 days after enrollment, or at dischargeMicrobiota changes in each set of throat swabs and sputum will be examined using 16s DNA / metagenome sequencing.

Secondary

MeasureTime frameDescription
Barthel-Index (BI)90 days after enrollmentBI values range from 0-100: The higher the score, the better the result.
Changes in the blood plasma metabolitesbaseline, 3 days, 7 days, 14 days after enrollment, or at dischargeUltra HPLC-tandem mass spectrometry will be used to test plasma metabolite expression in each group.
Utility-weighted modified Rankin scale score90 days after enrollmentUtility-weighted modified Rankin scale score. Values range from 0 to 10: The higher the score, the better the result.
The European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)90 days after enrollmentThe 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.

Contacts

Primary ContactJianwen Guo, Dr
306247680@qq.com13724899379
Backup ContactDou Wang, Dr
wd18292998840@163.com18292998840

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026