The Value of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis
- Conditions
- Sepsis, Severe
- Registration Number
- NCT05540808
- Lead Sponsor
- Shenzhen Second People's Hospital
- Brief Summary
The etiological diagnosis of sepsis is the key to guide clinical treatment. Metagenomic sequencing (mNGS) is very suitable for the diagnosis of sepsis due to its rapid, accurate and not easy to be disturbed by the environment. However, the conventional pathogen mNGS has potential risks such as low detection rate, loss of intracellular bacteria and fungi. At present, the latest fully targeted pathogen capture mNGS technology makes up for the shortcomings of conventional methods by bidirectional enrichment of pathogen nucleic acids. The aim of this study was to explore the value of fully targeted pathogen capture mNGS in improving etiological diagnosis in patients with sepsis compared with conventional methods.
- Detailed Description
This study planned to continuously collect samples from patients with sepsis who were admitted to the intensive care Unit of our hospital from 2022.08 to 2024.07, and conduct whole-target pathogen capture mNGS detection and follow-up etiological diagnosis based on blind method. The clinical diagnosis with clear etiology was taken as the gold standard.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 86
- Critical care patients aged ≥ 18 years old
- Patients with sepsis
- Lack of traditional pathogen detection results
- Discharge diagnosis without clear etiology
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method specificity up to 3 year The chance of a negative test in a sample judged pathogen-free by the gold standard
sensitivity up to 3 year The chance of testing positive for a pathogen in a sample judged by the gold standard
- Secondary Outcome Measures
Name Time Method