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 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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Infections (ARIs)
• Intervention / Treatment: Device: SPOTFIRE R/ST Diagnostic Test

Detailed Description

Antimicrobial resistance (AMR) is a critical public health challenge and a significant global burden. In the United States, most antibiotics are prescribed in outpatient settings, with suspicion or confirmation of a respiratory infection serving as a primary driver of unnecessary antibiotic use. This use is deemed inappropriate in approximately 30% of cases. This estimate differs based on setting and patient population. For example, a study assessing antibiotic use in a Veterans Affairs (VA) hospital demonstrated that 64.2% of patients received unnecessary antibiotics, with diagnoses such as bronchitis or nonspecific upper respiratory infections being the most likely to result in antibiotic use. Importantly, antibiotic overuse is not without consequences, as it is associated with adverse events that frequently lead to emergency department (ED) visits. Regardless of setting, acute respiratory conditions, such as acute bronchitis and rhinosinusitis are associated with the highest rates of inappropriate antibiotic prescribing. In cases of pharyngitis, similar trends have been observed. A 2020 study revealed that while Group A streptococcus (GAS) pharyngitis prevalence is 20-30% in children and 5-15% in adults, antibiotics were prescribed in 57% of cases across these groups. Notably, 50% of patients received antibiotics without prior GAS testing , even though laboratory testing is linked to more appropriate prescribing. In a pediatric study, unnecessary antibiotic prescribing occurred in 58% of outpatient visits for bronchitis or bronchiolitis, with diagnostic uncertainty identified as a key factor driving inappropriate use.

The role of multiplex rapid diagnostic tests (mRDTs) in the inpatient setting has been the focus of many studies. Its role on the outpatient care setting remains less studied. In outpatient settings, prescribing behaviors are influenced by factors such as the lack of an established patient-provider relationship, time constraints, patient satisfaction, and medicolegal considerations. Early evidence from studies implementing mRDTs suggests that molecular respiratory rapid diagnostic tests have the potential to positively impact patient care. In ED settings, studies have demonstrated benefits such as decreased test turnaround times (TAT), reduced lengths of stay , and more appropriate antiviral use. However, the impact on antibiotic use and ED length of stay remains mixed, with clinical decision-making and contextual factors playing crucial roles.

The Centers for Disease Control and Prevention (CDC) provides core elements for outpatient antibiotic stewardship programs (ASP), and studies performed in outpatient settings that leverage elements of these recommendations within multifactorial interventions have shown promise in improving stewardship outcomes. On study demonstrated that clinician education combined with audit and feedback improved adherence to prescribing guidelines for bacterial acute respiratory tract infections. Similarly, another study highlighted the effectiveness of a physician behavior change strategy paired with parental education in reducing antibiotic use. More recently, a new study has demonstrated that a multifaceted stewardship approach-including education for both providers and patients, electronic health record tools, benchmarking, and media campaigns-led to reduced antibiotic prescribing for respiratory infections in urgent care settings.

Performance metrics, such as those from the Healthcare Effectiveness Data and Information Set (HEDIS), play a vital role in evaluating antibiotic stewardship efforts. HEDIS measures, used by over 90% of U.S. health plans, help identify performance gaps. Analysis of 2008-2012 HEDIS data that described antibiotic prescribing for acute bronchitis demonstrated poor performance across insurance plans, with antibiotics prescribed in 80% of adult cases. Recently, a newly validated HEDIS measure has been introduced to assess antibiotic use for respiratory conditions, emphasizing "measurement" (i.e., utilization, improvement) as a core element of outpatient stewardship. This measure has broad support among antibiotic stewardship programs and health plan stakeholders and is used to evaluate care quality for over 200 million individuals.

Implementation science is a relatively recent arm of clinical research that aims to increase the adoption and sustainability of evidence-based interventions. Years of research has demonstrated that innovation uptake relies on contextual factors in addition to effectiveness. To fully understand the impact of diagnostic innovation on clinical outcomes, it is important to consider these elements together.

The BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® SPOTFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab (NPS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19; (Respiratory menu) or in throat swab (TS) specimens from individuals with signs and symptoms of pharyngitis (Sore Throat menu). Time from test initiation to result is approximately 15 minutes.

The SPOTFIRE R/ST Panel, designed for use with the SPOTFIRE System, is a PCR based sample-to-answer diagnostic test that simultaneously identifies nucleic acids from 15 different bacterial and viral organisms from nasopharyngeal swab (NPS) specimens, or 14 different bacterial and viral organisms from TS specimens, in transport media collected from individuals with signs and symptoms of respiratory infection or pharyngitis, respectively. The SPOTFIRE R/ST Panel uses a single instrument protocol with different reporting of analytes for the two sample types. Sample type is selected at the time of testing and the system's software controls the analyte reporting based on the selected sample type.

Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in NPS/TS specimens during the acute phase of infection. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of respiratory infection and/or pharyngitis are indicative of the presence of the identified microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a respiratory illness and/or pharyngitis may be due to infection with pathogens that are not detected by this test, or a respiratory tract infection that may not be detected by an NPS or TS specimen. Positive results do not rule out the possibility of coinfection with other organisms. The agent(s) detected by the SPOTFIRE R/ST Panel may not be the definite cause of disease.

At the clinician's discretion, additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be performed when evaluating a patient with possible respiratory tract infection and/or pharyngitis.

The SPOTFIRE R/ST Panel is intended for use by non-laboratory trained healthcare professionals in a facility holding a CLIA Certificate of Waiver (in the United States) or it may also be used by trained medical and laboratory professionals in a laboratory setting or under the supervision of a trained laboratory professional.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alyssa Duenes; Phone Number: 208-881-2410; Email: alyssa.duenes@biomerieux.com
• Study Contact Backup: Name: Andrea Prinzi, PhD; Phone Number: 303-646-7446; Email: andrea.prinzi@biomerieux.com

Study Locations

• United States
  • Alabama
    • Gardendale, Alabama, United States, 35071
      • Recruiting
      • American Family Care - Gardendale
      • Contact: Beverly McKee, PharmD; Phone Number: 205-271-5047; Email: bmckee@americanfamilycare.com
      • Principal Investigator: Jessica Higginbotham, PharmD
    • Hoover, Alabama, United States, 35226
      • Recruiting
      • American Family Care - Grove
      • Principal Investigator: Jessica Higginbotham, PharmD
      • Contact: Jessica Higginbotham, PharmD; Phone Number: 205-421-2103; Email: jlhigginbotham@AMERICANFAMILYCARE.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic utilization for respiratory conditions (HEDIS AXR)	The percent of episodes for patients one year and older with a diagnosis of a respiratory condition that results in an antibiotic prescribing event. (Note: while the HEDIS measure includes all patients greater than 3 months of age, AFC's electronic health record (EHR) stores age as whole years. Excluding patients with a reported age of 0 from the baseline data resulted in only 0.03% of observations lost.)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness outcome	This study employs a pre-post design with a difference-in-differences (DID) analysis to estimate the treatment effect of implementing the Spotfire R/ST assay paired with training and education. The DID approach compares changes in outcomes over time between the intervention and control groups, accounting for baseline differences and secular trends. The DID model will estimate the causal effect of the intervention (Spotfire) using an interaction term between time (pre- vs. post-intervention) and treatment group (Spotfire vs. standard of care): Y=β0+β1[Time]+β2[Intervention]+β3[Time*Intervention]+β4[Covariates]+ϵ	From date of first enrollment until enrollment goal is met, approximately 16 weeks
Percentage of episodes for patients one year and older with a diagnosis of acute bronchitis/bronchiolitis that did not result in an antibiotic prescribing event	The percentage of episodes that were not prescribed an antibiotic	From date of first enrollment until enrollment goal is met, approximately 16 weeks
Percentage of episodes for members 3 years of age and older with a diagnosis of pharyngitis, dispensed an antibiotic and received a group A streptococcus test for the episode (HEDIS CWP)		From date of first enrollment until enrollment goal is met, approximately 16 weeks
Percentage of episodes for patients 3 years of age or older with a positive Group A Strep (GAS) test and prescribed an antibiotic		From date of first enrollment until enrollment goal is met, approximately 16 weeks
Percentage of patients with a positive influenza test who receive an antiviral for influenza		From date of first enrollment until enrollment goal is met, approximately 16 weeks
Percentage of patients without a positive influenza test with a clinical diagnosis of influenza who receive an antiviral for influenza		From date of first enrollment until enrollment goal is met, approximately 16 weeks
Consumer Assessment of Healthcare Providers and Systems (CAHPS) clinician and group survey (patient satisfaction)	Minimum value: 0 Maximum value: 10 Higher scores indicate a better outcome	Administered two weeks before active intervention phase begins
Workflow	Specific measures to be determined from pre-intervention qualitative survey with American Family Care urgent care providers. Workflow measures will not be scored using a scale.	From date of first enrollment until enrollment goal is met, approximately 16 weeks
Length of patient visit	From check-in to discharge	Day 1
Implementation outcomes	The information from the provider pre survey will be used to inform the bundled intervention and make modifications as necessary during the passive implementation period. Pre and post survey results will be compared to assess implementation success	From date of first enrollment until enrollment goal is met, approximately 16 weeks
Reach outcomes	Part of the Reach, effectiveness, adoption, implementation, maintenance (RE-AIM) outcomes being assessed. Quantitative: Total number of consistently employed (nonfloat) employees that prescribe antimicrobials at the intervention site; Proportion of staff members who participate in the pre-intervention educational session(s) Qualitative • Pre-survey to understand attitudes around both prescribing practices and respiratory mPCR diagnostics, willingness to adopt new technologies and processes/ participate in implementation program.	From date of first enrollment until enrollment goal is met, approximately 16 weeks
Adoption Outcomes	Part of the Reach, effectiveness, adoption, implementation, maintenance (RE-AIM) outcomes being assessed. Quantitative: Porportion of staff at the intervention site who participate in the education session; Results of audit and feedback process pre/post in the intervention site Qualitative • Provider satisfaction, willingness to adopt new technology for respiratory infection diagnosis	From date of first enrollment until enrollment goal is met, approximately 16 weeks

Collaborators and Investigators

• Sponsor: BioMérieux
• Investigators: Principal Investigator: Andrea Prinzi, PhD, BioMérieux

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: SPOTFIRE; R/ST; BioFire; BioMérieux
• Other Study ID Numbers: BFD-BIR-24-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes