Status:
NOT_YET_RECRUITING
Clinical Impact of Rapid Molecular Testing for Pathogens in Patients With Severe Acute Respiratory Illness : A Pragmatic Trial
Lead Sponsor:
National Taiwan University Clinical Trial Center
Collaborating Sponsors:
Taipei Veterans General Hospital, Taiwan
Conditions:
Community-Acquired Pneumonia (CAP)
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Community-acquired pneumonia (CAP) is among the most common reasons for emergency department (ED) visits. A clear understanding of the likely pathogens is essential for the rapid institution of adequa...
Detailed Description
Community-acquired pneumonia is among the most common reasons for emergency department (ED) visits and can be caused by both viral and bacterial pathogens. A clear understanding of the likely pathogen...
Eligibility Criteria
Inclusion
- Admitted to the ED
- Age ≥18 years old
- Diagnosis of SARI -modified from the World Health Organization definition:
- history of fever or measured fever of ≥ 38 C° and cough
- with onset within the last 10 days.
- requires hospitalization.
- with SpO2 on presentation less than 95% or respiratory rate more than 20 per minute, or requirement of intubation and mechanical ventilation.
Exclusion
- Patients receiving palliative care
- Patients who declined sample collection
- Patients fail to provide written informed consent.
- Patients highly suspected or diagnosed pulmonary non-infectious disease (tumor, immune disease, etc) without evidence of infection.
- Patients diagnosed with COVID-19 within last 3 months.
- HIV-infected patients.
- Off work hour collected samples will be excluded from the study.
- Patients who died or being transitioned to comfort care within 48 hours of enrollment.
- Study Population Description Inclusion criteria will be 1) ED patients age 18 or older; 2) presenting to the emergency department with acute severe respiratory illness. We define a case of severe acute respiratory illness (SARI) according to a previously suggested WHO case definition for all adults in whom onset of illness occurred within 7 days of admission. We defined SARI in adult as physician-diagnosed lower respiratory tract infection (LRTI) with SpO2 on presentation less than 95% or respiratory rate more than 20 per minute, or requirement of intubation and mechanical ventilation.
- Sampling Method: random sampling
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06605352
Start Date
September 20 2024
End Date
December 1 2026
Last Update
September 20 2024
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Zhongzheng Dist, Taiwan, 100