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

Acute Respiratory Infection Clinical Trial

— RAPID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756753
• Other study ID #: 18-1492
• Status: Completed
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 913
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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 >37.8°C 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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Lower Respiratory Tract Illness
• Respiratory Pathogens
• Respiratory Tract Infections
• Upper Respiratory Tract Illness

Intervention

Diagnostic Test:
• Results available to provider
Results of point of care testing are given to provider

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Biofire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Days of Hospitalization	Proportion of patients hospitalized within 10 days of enrollment in the study	day 0-10
Secondary	Number of repeat ED visits	Number of repeat ED visits within 10 days of enrollment in the study	day 0-10
Secondary	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
Secondary	Relative clinical charges	Relative clinical charges for ED visit in which a subject is enrolled in the study.	day 0