Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway

Completed · Not applicable

Conditions studied: Viral Infection, Acute Respiratory Infection, Upper Resp Tract Infection

In brief

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.

Key facts

Study ID

NCT05467007

Run by

Andrew Meltzer

People needed

360

Starts

2022-04-04

Expected to finish

2023-06-01

Last updated by the study team

2024-09-19

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >7
• Clinically stable
• Must present with one symptom of respiratory illness (e.g., cough, sneezing, runny or stuffy nose, sore throat, headaches, muscle aches, trouble breathing, shortness of breath, and/or fever).

You may not qualify if…

• Patient is unable to provide informed consent
• Chronic symptoms (>14 days) or asymptomatic
• Unstable (or "too sick" to consent)
• Prisoner or ward of state
• Non-English speaker

Where it is running

• GW Immediate & Primary Care - McPherson Square — Washington D.C., District of Columbia, United States
• GW Immediate & Primary Care - Rhode Island Ave — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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