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Completed
NCT07513519
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
Conditions: Acute Respiratory Infections (ARIs)
Sex: All
Ages: 1 Year – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 800
Sponsor: BioMérieux
Location: American Family Care - Gardendale Gardendale Alabama
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07513519). StuddyBuddy aggregates publicly available trial information.