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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Infection; Lower Respiratory Tract Illness; Respiratory Pathogens; Upper Respiratory Tract Illness
• Intervention / Treatment: Diagnostic test: Results available to provider

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.

• Study Type: Interventional
• Enrollment (Actual): 913
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group- results known; Providers of patients enrolled in this arm of the study will be notified of the point of care respiratory testing results	Diagnostic test: Results available to provider; Results of point of care testing are given to provider
No Intervention: Control group- results not known; Providers of patients enrolled in the study will not be notified of the point of care respiratory testing results

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit	Proportion of children who are prescribed an antibiotic at the ED visit.	day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of children treated with influenza antiviral at the ED visit	Proportion of patients treated with influenza antiviral at the ED visit in which a subject is enrolled in the study.	day 0
Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit	Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit in which a subject is enrolled in the study.	day 0
ED length of stay (hours)	Length of stay (in hours) in emergency department at the visit in which a subject is enrolled in the study.	day 0
Days of Hospitalization	Proportion of patients hospitalized within 10 days of enrollment in the study	day 0-10
Number of repeat ED visits	Number of repeat ED visits within 10 days of enrollment in the study	day 0-10
Number of tests ordered	Number of tests ordered (labs, imaging, microbiologic testing) during visit in which a subject is enrolled in the study.	day 0
Relative clinical charges	Relative clinical charges for ED visit in which a subject is enrolled in the study.	day 0

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Biofire

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 18-1492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No