Recruiting

Spotfire R/ST

Sponsor:

BioMérieux

Code:

NCT07513519

Conditions

Acute Respiratory Infections (ARIs)

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

SPOTFIRE R/ST Diagnostic Test

Study Details

Brief 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.

Conditions

Acute Respiratory Infections (ARIs)

Study ID

NCT07513519

Start date

Dec 22, 2025

Status verified date

Feb, 2026

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

800 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Intervention

At the intervention site, subjects meeting the inclusion and exclusion criteria, and who provide consent to participate in the study, will have a respiratory sample tested on the SPOTFIRE R/ST Panel, with results used by the treating clinician to guide management . At the end of the visit, enrolled patients will take a satisfaction survey, based on the AHRQ-validated CAHPS survey. Providers at the intervention site will participate in the AMS and implementation science interventions designed in the pre-implementation phase.

no intervention: Control

At the control site and at the discretion of the treating clinician, patients will have their respiratory samples tested on the clinic's usual standard of care (SOC) respiratory antigen tests, with results used by the treating clinician to guide management. Patients at the control site who meet inclusion and exclusion criteria and agree to participate will also take the CAHPS-based satisfaction survey.

Interventions

SPOTFIRE R/ST Diagnostic Test

At the intervention site, subjects meeting the inclusion and exclusion criteria, and who provide consent to participate in the study, will have a respiratory sample tested on the SPOTFIRE R/ST Panel, with results used by the treating clinician to guide management . At the end of the visit, enrolled patients will take a satisfaction survey, based on the AHRQ-validated CAHPS survey

Primary outcome measure

  • Antibiotic utilization for respiratory conditions (HEDIS AXR) [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Alyssa Duenes

208-881-2410alyssa.duenes@biomerieux.com

Andrea Prinzi, PhD

303-646-7446andrea.prinzi@biomerieux.com

Locations

American Family Care - Gardendale

Recruiting

Gardendale, Alabama, United States, 35071

Contacts

Beverly McKee, PharmD

205-271-5047bmckee@americanfamilycare.com

Principal Investigator:

Jessica Higginbotham, PharmD

American Family Care - Grove

Recruiting

Hoover, Alabama, United States, 35226

Contacts

Jessica Higginbotham, PharmD

205-421-2103jlhigginbotham@AMERICANFAMILYCARE.com

Principal Investigator:

Jessica Higginbotham, PharmD

More Information

Sponsor

BioMérieux

Last update posted

Apr 7, 2026

Last verified

Feb, 2026

Keywords

  • SPOTFIRE
  • R/ST
  • BioFire
  • BioMérieux

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BioMérieux on 2026-04-07.