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Impact of a Multiplex Respiratory PCR Test on Outcomes for Patients Presenting With Respiratory Illness in the Urgent Care Setting: A Hybrid-Effectiveness Quasi-Experimental Trial

Who can join

Ages 1 and older · All sexes

Inclusion Criteria:

* Patients older than 1 year
* Patients presenting with signs and symptoms of acute respiratory illness including but not limited to bronchitis, bronchiolitis, rhinitis, pharyngitis, tonsillitis, and laryngitis
* First visit for respiratory indication within the study period

Exclusion Criteria:

* Patients younger than 1 year
* Patients for which there is a clinical suspicion of pneumonia (i.e., severe illness on presentation requiring hospitalization or not eligible for urgent care)
* Patients experiencing symptoms for \> 10 days
* Patients with significant respiratory comorbidities, including COPD, emphysema, pulmonary fibrosis, diseases causing chronic respiratory tract inflammation, and other conditions
* Patients with other significant oropharyngeal or upper respiratory comorbidities or conditions, including but not limited to nasal deformations, peritonsillar abscess
* Had a previous visit for respiratory indication within the study period

About the study

This research study will use a hybrid effectiveness-implementation type 1 design to assess effectiveness of the Spotfire R/ST assay in the urgent care setting. A hybrid effectiveness-implementation type 1 study primarily focuses on the effectiveness of an intervention (e.g., use of Spotfire R/ST) but also simultaneously allows for the collection of data on the barriers and facilitators of implementing the Spotfire R/ST test in the real-world urgent care setting.

What is being tested

• SPOTFIRE R/ST Diagnostic Test (device)

Sponsor: BioMérieux · Participants: 800 · Started: Dec 22, 2025

Contact the study team

• Alyssa Duenes · Phone: 208-881-2410
• Andrea Prinzi, PhD · Phone: 303-646-7446

Official record on ClinicalTrials.gov — NCT07513519

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.