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N/A N=360 Randomized Diagnostic

Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway

Viral Infection · Acute Respiratory Infection · Upper Resp Tract Infection

Enrolled (actual)
360
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Satisfaction With Time to Receive Result — 180; 53; 3; 72 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
BioFire® Respiratory Panel 2.1-EZ (Diagnostic_test)
Age
Pediatric, Adult, Older Adult · 7+ yrs
Sex
All
Sponsor
Andrew Meltzer
Primary completion
Jan 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Satisfaction With Time to Receive Result
180; 53; 3; 72
SECONDARY
Confidence in Testing
111; 37; 43; 57; 29; 30
SECONDARY
Intention to Self Isolate
74; 50; 98; 45; 9; 27
SECONDARY
Plan to Seek Care From Another Doctor or Healthcare Facility
30; 17; 134; 80; 19; 28
SECONDARY
Will Patient Plan for Work Absence
62; 60; 78; 42; 43; 23
SECONDARY
Did the Time to Receive Test Results Affect You and Prevent You From Doing Activities You Normally Would do?
26; 38; 130; 86
SECONDARY
I am Satisfied With the Time it Took to Receive the Test Results.
145; 73; 7; 16; 4; 33
SECONDARY
Were Antibiotics Prescribed as Part of the IPC Visit for Respiratory Illness?
52; 27; 103; 77
SECONDARY
Confidence in Patient's Cause of Illness
10; 15; 20; 41; 125; 48

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.

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05467007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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