Microbe-host Interaction Relationship in Patients With Stroke-relatedPneumonia

NCT06161298 | Unknown DMC

• 1 other identifier: SAP20231201
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke-related Pneumonia

Keywords

Stroke-related pneumonia; micropopulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Utility-weighted modified Rankin scale score

  90 days after enrollment

• The European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)

  90 days after enrollment

• Barthel-Index (BI)

  90 days after enrollment

• Changes in the blood plasma metabolites

  baseline, 3 days, 7 days, 14 days after enrollment, or at discharge

Study Arms (3)

Healthy control group

age\> 18, without lung disease

NSAP group

patients with no stroke pneumonia

SAP group

Those diagnosed with stroke-related pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Biospecimen

Retention: SAMPLES WITH DNA

All biological specimens (including throat swabs, sputum, blood) will be stored in the biological resource center of the study site after obtaining written informed consent from all subjects who volunteered to participate in the clinical study.

Study Officials

• Jianwen Guo, Dr

  Guangdong Province Hospital of Tradtional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Jianwen Guo, Dr

CONTACT

13724899379; 306247680@qq.com

Dou Wang, Dr

CONTACT

18292998840; wd18292998840@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 7, 2023
• Study Start: December 20, 2023
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share