Using advanced sequencing to diagnose pneumonia
Impact of Incorporating Metagenomic Next-generation Sequencing in the Management of Pneumonia on Diagnostic Efficiency and Outcomes: A Randomized Controlled Trial
This study is testing if a new DNA sequencing method can help doctors better diagnose severe pneumonia in adults who need breathing support, compared to regular testing methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05979350 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized, multi-center trial evaluates the effectiveness of metagenomic next-generation sequencing (mNGS) in diagnosing severe pneumonia compared to standard diagnostic methods. Participants will be randomly assigned to receive either standard care or standard care with mNGS for pathogen detection. The study aims to assess the accuracy of pathogen identification, the appropriateness of antimicrobial therapy, length of hospital stay, and mortality rates. Eligible patients are adults with severe pneumonia requiring intubation and mechanical ventilation, and the study will follow them for 28 days or until discharge or death.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are intubated and admitted to the ICU with a diagnosis of severe pneumonia.
Not a fit: Patients with a life expectancy of less than four weeks or those who have already undergone specific pathogen testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the accuracy of pneumonia diagnoses and enhance patient outcomes through more effective treatment.
How similar studies have performed: Other studies have shown promise in using advanced sequencing techniques for pathogen detection, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Presenting to the ICU with a diagnosis of pneumonia (fulfilled with both radiographic and clinical criteria) 2. Adults aged ≥18 years 3. Orotracheally intubated 4. ICU admission for \<24 hours 5. APACHE II score \<35 on ICU admission Exclusion Criteria: 1. Life expectancy below 4 weeks 2. With an existing directive to withhold life-sustaining treatment 3. Patients not willing or able to provide a lower respiratory tract sample at ICU admission 4. Previous work-up has identified specific pathogens which can account for the index event of pneumonia 5. Multiplex PCR or NGS testing has been done for pathogen detection before screening
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Sheng-Yuan Ruan, MD — National Taiwan University Hospital
- Study coordinator: Sheng-Yuan Ruan, MD
- Email: syruan@ntu.edu.tw
- Phone: 886-2-23123456
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.