Clinical trial NCT03756753: The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics
Official title: The RAPID Trial: Randomized Controlled Trial Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Pathogens
Upper Respiratory Tract Illness
Lower Respiratory Tract Illness
Acute Respiratory Infection
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Biofire
First posted: 2018-11-28
Enrollment: 913
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: OTHER

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

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit
timeFrame: day 0
Secondary outcomes:
measure: Proportion of children treated with influenza antiviral at the ED visit
timeFrame: day 0
measure: Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit
timeFrame: day 0
measure: ED length of stay (hours)
timeFrame: day 0
measure: Days of Hospitalization
timeFrame: day 0-10
measure: Number of repeat ED visits
timeFrame: day 0-10
measure: Number of tests ordered
timeFrame: day 0
measure: Relative clinical charges
timeFrame: day 0
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References:
citation: Rao S, Lamb MM, Moss A, Mistry RD, Grice K, Ahmed W, Santos-Cantu D, Kitchen E, Patel C, Ferrari I, Dominguez SR. Effect of Rapid Respiratory Virus Testing on Antibiotic Prescribing Among Children Presenting to the Emergency Department With Acute Respiratory Illness: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2111836. doi: 10.1001/jamanetworkopen.2021.11836.