Using advanced sequencing to improve infection diagnosis in patients with severe liver disease
Clinical Application of Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection: a Multicenter, Prospective Study
Nanfang Hospital, Southern Medical University · NCT06039696
This study is testing if a new blood test can help doctors find infections faster in patients with severe liver disease and improve their treatment and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 850 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06039696 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of pathogenic metagenomic next-generation sequencing (mNGS) in diagnosing infections in patients with acute decompensated cirrhosis. It will assess how mNGS can optimize the use of anti-infective drugs, the rate of patient recovery, and the characteristics of pathogens involved. Additionally, the study will investigate the incidence and risk factors associated with cytomegalovirus (CMV) reactivation in these patients. By analyzing microbial cell-free DNA from blood samples, the study seeks to provide insights into the clinical outcomes of decompensated cirrhosis patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with a diagnosis of cirrhosis experiencing acute decompensation.
Not a fit: Patients over 80 years old, those with malignancies, or individuals receiving immunosuppressive therapy for non-hepatic diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of infections in patients with decompensated cirrhosis, improving treatment outcomes.
How similar studies have performed: While studies on mNGS in cirrhosis patients are rare, the technique has shown promise in other clinical settings, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old. * Diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not. * Acute decompensation: ascites, digestive hemorrhage or hepatic encephalopathy. Exclusion Criteria: * Age \> 80 years old. * Malignancy of liver or other organs (including leukemia). * Receiving immunosuppressive agents for non-hepatic diseases. * HIV infection.
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Chen Jinjun — Nanfang Hospital, Southern Medical University
- Study coordinator: Chen Jinjun
- Email: chjj@smu.edu.cn
- Phone: +86 020 62787310
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.
Conditions: Cirrhosis, Liver