Evaluating advanced sequencing for diagnosing spinal infections
Diagnostic Efficacy of Metagenomic Next-generation Sequencing in Patients With Spinal Infections: A Retrospective Study
This study is testing if a new DNA sequencing method can do a better job than standard lab tests at diagnosing spinal infections in patients who might have them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06172153 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of traditional laboratory methods with second-generation high-throughput sequencing in diagnosing spinal infections. It focuses on patients suspected of having these infections based on established clinical criteria. The study is observational and retrospective, analyzing data from patients who underwent various diagnostic examinations, including laboratory tests and imaging. The goal is to determine if metagenomic sequencing provides superior diagnostic accuracy compared to conventional methods.
Who should consider this trial
Good fit: Ideal candidates are patients suspected of spinal infections based on specific clinical criteria.
Not a fit: Patients who do not undergo the necessary laboratory and histopathological examinations will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and timely diagnoses of spinal infections, improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies using advanced sequencing techniques have shown promising results in other infection diagnostics.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: "Patients suspected of spinal infections, as per the American Infectious Diseases Society's 2015 criteria for primary vertebral osteomyelitis, were identified based on their clinical symptoms, laboratory tests, and imaging examinations. All cases included in the study underwent laboratory examinations, histopathological examinations, and second-generation high-throughput sequencing (metagenomic sequencing)." Exclusion Criteria: "The absence of laboratory examinations, histopathological examinations, and results from second-generation high-throughput sequencing (metagenomic sequencing)."
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen memorial hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Chunhai Li, MD — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Chunhai Li, MD
- Email: lichhai@mail.sysu.edu.cn
- Phone: 18602079796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.