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

NCT ID: NCT03756753

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

913 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-03

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Patients will be enrolled in the study, and will not initially know their study arm. After enrollment, the professional research assistant (PRA) will find out the study arm. Providers will be notified of the results for the intervention group. Providers are able to let patients know of their results.

Study Groups

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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

Group Type EXPERIMENTAL

Results available to provider

Intervention Type DIAGNOSTIC_TEST

Results of point of care testing are given to provider

Control group- results not known

Providers of patients enrolled in the study will not be notified of the point of care respiratory testing results

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Results available to provider

Results of point of care testing are given to provider

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biofire

UNKNOWN

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34086034 (View on PubMed)

Other Identifiers

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18-1492

Identifier Type: -

Identifier Source: org_study_id