Using the Spotfire R/ST multiplex respiratory PCR test in urgent care to guide treatment for acute respiratory infections
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
This project will try the Spotfire R/ST multiplex PCR test in urgent care to see if it helps clinicians choose the right treatments for patients older than 1 year with acute respiratory infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | BioMérieux Industry-sponsored |
| Locations | 2 sites (Gardendale, Alabama and 1 other locations) |
| Trial ID | NCT07513519 on ClinicalTrials.gov |
What this trial studies
This interventional, hybrid effectiveness-implementation type 1 trial implements the Spotfire R/ST multiplex respiratory PCR in two American Family Care urgent care clinics to measure clinical outcomes and gather real-world implementation data. Eligible patients are older than 1 year presenting with acute respiratory symptoms within 10 days and without clinical suspicion of pneumonia or significant chronic respiratory comorbidities. The design is quasi-experimental and combines measurement of antibiotic prescribing and other clinical outcomes with surveys and observations of barriers and facilitators to test adoption. Results will compare care and prescribing patterns when the rapid PCR test is used versus usual urgent care practice while documenting practical issues for broader rollout.
Who should consider this trial
Good fit: Ideal candidates are patients older than 1 year who present to a participating urgent care within 10 days of acute respiratory symptoms, are not severely ill or suspected to have pneumonia, and have not had a prior respiratory visit during the study period.
Not a fit: Patients younger than 1 year, those with suspected pneumonia or severe illness requiring hospitalization, symptoms longer than 10 days, significant chronic respiratory or oropharyngeal comorbidities, or repeat respiratory visits during the study period are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the test could reduce unnecessary antibiotic use and related adverse events by identifying viral and bacterial causes of respiratory illness more quickly.
How similar studies have performed: Similar rapid multiplex respiratory PCR platforms (for example, BioFire assays) have improved pathogen detection and in some outpatient studies reduced inappropriate antibiotic prescribing, though effects vary by setting and implementation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gardendale, Alabama and 1 other locations
- American Family Care - Gardendale — Gardendale, Alabama, United States (Recruiting)
- American Family Care - Grove — Hoover, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Prinzi, PhD — BioMérieux
- Study coordinator: Alyssa Duenes
- Email: alyssa.duenes@biomerieux.com
- Phone: 208-881-2410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.