Evaluating mNGS Technology for Diagnosing Pulmonary Infections in Diabetic Patients
A Multicenter Clinical Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections
This study is testing a new way to diagnose lung infections in people with diabetes to see how it compares to standard methods and to understand their treatment needs better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05552872 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with diabetes who have pulmonary infections, aiming to identify the epidemiology and treatment status of these conditions. It employs a cross-sectional multicenter approach where participants undergo clinical questionnaires, laboratory examinations, and treatment monitoring. Both routine clinical pathogen culture and metagenomic next-generation sequencing (mNGS) are utilized for pathogen detection. The study also includes a nested case-control analysis comparing pneumonia patients with and without diabetes to explore differences in the immune response and etiologic spectrum.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with pulmonary infections and diabetes.
Not a fit: Patients who do not have a confirmed diagnosis of pulmonary infection or those who are unable to comply with follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy for pulmonary infections in diabetic patients, potentially reducing mortality rates.
How similar studies have performed: While similar studies have explored the use of mNGS in infectious diseases, this specific application in diabetic patients with pulmonary infections is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis by pathogen examination: positive * Diagnosis through X-ray or CT: characteristic features of pulmonary infection * Age older than 18 years Exclusion Criteria: * Irregular follow-up and lost follow-up * Withdraw from the study for any reason
Where this trial is running
Shanghai, Shanghai
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jieming Qu, Ph.D., M.D. — China, Shanghai Ruijin Hospital Shanghai Jiao Tong University School of Medicine
- Study coordinator: Min Zhou, Ph.D., M.D.
- Email: doctor_zhou_99@163.com
- Phone: +8613681779642
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.