CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 360 enrolled
Drug / intervention
BioFire® Respiratory Panel 2.1-EZother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05467007
NCT05467007N/ACompleted

Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway (URGENT): A Randomized Control Trial of Respiratory PCR Versus Standard Care

Andrew Meltzer·interventional·Posted Jul 20, 2022·Updated Sep 19, 2024

In Brief

A clinical study evaluating BioFire® Respiratory Panel 2.1-EZ for Viral Infection and 2 related conditions. Completed, enrolled 360 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsBioMérieux

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 20, 2022
Enrollment StartApr 4, 2022
Primary CompletionJan 1, 2023
Study CompletionJun 1, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.9 years ago

Interventions

BioFire® Respiratory Panel 2.1-EZother

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.