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
Recruiting now · Not applicable
Conditions studied: Acute Respiratory Infections (ARIs)
In brief
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.
Key facts
- Study ID
- NCT07513519
- Run by
- BioMérieux
- People needed
- 800
- Starts
- 2025-12-22
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2026-04-07
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- American Family Care - Gardendale — Gardendale, Alabama, United States (enrolling)
- American Family Care - Grove — Hoover, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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