The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 18
Updated:12/29/2018
Start Date:January 3, 2019
End Date:December 1, 2020
Contact:Suchitra Rao
Email:SUCHITRA.RAO@UCDENVER.EDU
Phone:303-207-0184

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The RAPID Trial: Randomized Controlled Trial Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics

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 group - results available to medical providers, or the control group- results
not available to medical providers.

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 be children 1 month to 18 years of age presenting to the Children's
Hospital Colorado (CHCO) Emergency Department with influenza like illness who are triaged as
level 3, 4, or 5 by the Emergency Severity Index, representing the typical patient population
who are evaluated in an urgent care setting. All eligible participants will undergo a
nasopharyngeal swab and point of care testing, and participants will be allocated 1:1 by
computer-generated randomization to either the intervention group - test result available to
providers, or the control group- test result not available (routine clinical care). The
investigators will compare the clinical outcomes between the two groups.

Inclusion Criteria:

1. Age 1 month to < 18 years

2. 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

3. 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

4. Triage Level 3,4,5 based on Emergency Severity Index (refer to Appendix B for
algorithm)

Exclusion Criteria:

1. Respiratory symptom duration > 14 days

2. Previous enrollment in study within past 14 days

3. Nurse-only visit

4. Triage levels 1 and 2 based on Emergency Severity Index
We found this trial at
1
site
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Suchitra Rao, MBBS
Phone: 303-724-3285
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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