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Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway

NCT05467007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2024-09-19

Study results available
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Summary

Rapid diagnosis and precise treatment have become possible with multiplex polymerase chain reaction (PCR) panels that can identify a variety of causative agents of acute respiratory illnesses such as bacterial and viral infections in one urgent care visit. While real-time PCR is currently used as a standard for diagnosing acute respiratory illnesses such as influenza due to its high sensitivity and specificity, it typically takes several hours for results which is unfavorable in the urgent care setting. Highly sensitive and rapid random-access PCR tests provide the sensitivity and specificity needed to both rapidly and accurately diagnose acute respiratory illnesses. Similar PCR panels have been used in previous research for the diagnosis of gastrointestinal illnesses in the emergency department and point-of-care testing for hospitalized adults presenting with acute respiratory illness. In this study, the investigators aim to determine if a rapid multiplex PCR test for urgent care patients with symptomatic upper respiratory infections can improve patient and provider-reported outcomes. This study utilizes the Biofire® FilmArray Panel (RP2.1-EZ) which in previous studies has been shown to be highly effective in diagnosing acute respiratory illnesses.

Conditions

Interventions

DIAGNOSTIC_TEST

BioFire® Respiratory Panel 2.1-EZ

BioFire RP2.1-EZ Panel uses a syndromic approach to quickly identify SARS-CoV-2, along with 18 additional viral and bacterial pathogens in patients suspected of SARS-CoV-2. This PCR test provides results in about 45 minutes.

Sponsors & Collaborators

  • BioMérieux

    collaborator INDUSTRY

  • Andrew Meltzer

    lead OTHER

Principal Investigators

  • Andrew Meltzer, MD · Clinical Research Director, Department of Emergency Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-04
Primary Completion
2023-01-01
Completion
2023-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05467007 on ClinicalTrials.gov