Skip to main content
OpenTrials
Completed

NCT Number: NCT03756753

The RAPID 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Results available to provider

Diagnostic Test

Results of point of care testing are given to provider

Primary outcomes

  1. Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit

    Time frame: day 0

    Proportion of children who are prescribed an antibiotic at the ED visit.

Secondary outcomes

  1. Proportion of children treated with influenza antiviral at the ED visit

    Time frame: day 0

    Proportion of patients treated with influenza antiviral at the ED visit in which a subject is enrolled in the study.

  2. Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit

    Time frame: day 0

    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.

  3. ED length of stay (hours)

    Time frame: day 0

    Length of stay (in hours) in emergency department at the visit in which a subject is enrolled in the study.

  4. Days of Hospitalization

    Time frame: day 0-10

    Proportion of patients hospitalized within 10 days of enrollment in the study

  5. Number of repeat ED visits

    Time frame: day 0-10

    Number of repeat ED visits within 10 days of enrollment in the study

  6. Number of tests ordered

    Time frame: day 0

    Number of tests ordered (labs, imaging, microbiologic testing) during visit in which a subject is enrolled in the study.

  7. Relative clinical charges

    Time frame: day 0

    Relative clinical charges for ED visit in which a subject is enrolled in the study.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • BioFire Diagnostics, LLC

Registry information

Official study title

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

Acronym: RAPID

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 28, 2018
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.