Status:
ACTIVE_NOT_RECRUITING
Metagenomic NGS for Diagnosis of Pneumonia
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Taiwan University Hospital Hsin-Chu Branch
Far Eastern Memorial Hospital
Conditions:
Pneumonia
Diagnosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this randomized controlled trial, we aim to evaluate the efficacy of incorporating mNGS in the management of pneumonia on efficiency and accuracy of causative pathogen identification, proportion of...
Detailed Description
This is an open-label, randomized, multi-center, phase 2 study that will evaluate the efficacy of incorporating mNGS in the management of severe pneumonia on accuracy and efficiency of achieving defin...
Eligibility Criteria
Inclusion
- Presenting to the ICU with a diagnosis of pneumonia (fulfilled with both radiographic and clinical criteria)
- Adults aged ≥18 years
- Orotracheally intubated
- ICU admission for \<24 hours
- APACHE II score \<35 on ICU admission
Exclusion
- Life expectancy below 4 weeks
- With an existing directive to withhold life-sustaining treatment
- Patients not willing or able to provide a lower respiratory tract sample at ICU admission
- Previous work-up has identified specific pathogens which can account for the index event of pneumonia
- Multiplex PCR or NGS testing has been done for pathogen detection before screening
Key Trial Info
Start Date :
August 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2025
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05979350
Start Date
August 7 2023
End Date
November 30 2025
Last Update
November 19 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan