Status:
COMPLETED
The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Biofire
Conditions:
Respiratory Pathogens
Upper Respiratory Tract Illness
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
The RAPID trial is a randomized controlled trial that looks at the clinical impact of a rapid respiratory test in a pediatric emergency department. Participants will be randomized to the intervention ...
Detailed Description
The RAPID trial is a randomized controlled trial of rapid respiratory viral testing in children presenting to an Emergency Department setting with acute respiratory symptoms. The patient cohort will b...
Eligibility Criteria
Inclusion
- Age 1 month to \< 18 years
- For children aged 1 month to 12 months of age: Presentation to the study sites with temperature \> 37.8°C or cough, sore throat, runny nose or nasal congestion
- For children aged \> 1 year to 18 years of age: Presentation to the study sites with influenza like illness, defined as temperature of \>37.8⁰C and at least one of the following: cough, sore throat, runny nose or nasal congestion
- Triage Level 3,4,5 based on Emergency Severity Index (refer to Appendix B for algorithm)
Exclusion
- Respiratory symptom duration \> 14 days
- Previous enrollment in study within past 14 days
- Nurse-only visit
- Triage levels 1 and 2 based on Emergency Severity Index
Key Trial Info
Start Date :
January 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
913 Patients enrolled
Trial Details
Trial ID
NCT03756753
Start Date
January 3 2019
End Date
December 31 2020
Last Update
November 9 2021
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045