Upper Respiratory InfectionPROTECTNCT06765135
Point of Care Respiratory Pathogen Testing for Antibiotic Stewardship in Primary Care
A study testing Clinician Survey, Focus Group and Biofire Spotfire Respiratory (R) panel in people with Upper Respiratory Infection, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this study is to understand the use of point of care (POC) testing devices in primary care offices to help clinicians diagnose and appropriately treat patients who have symptoms of upper respiratory infections (URIs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Respiratory Infection
- What is being tested?
- Clinician Survey, Focus Group and Biofire Spotfire Respiratory (R) panel
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years
- Symptoms of an upper respiratory infection to include: cough, rhinorrhea, nasal congestion, fever, sore throat, ear pain/fullness, sinus pain
Who cannot join
- Age < 18 years of age
- No relevant upper respiratory symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pennsylvania Primary Care Practice
Philadelphia, Pennsylvania, 19104
About this study
The goal of this study is to understand the use of point of care (POC) testing devices in primary care offices to help clinicians diagnose and appropriately treat patients who have symptoms of upper respiratory infections (URIs).
The study will use the BIOFIRE® SPOTFIRE® Respiratory (R) Panel testing device, which is FDA-cleared and CLIA-Waived. This panel can identify up to 15 different viruses and bacteria that can cause URIs.
Read more
These POC devices will be installed in primary care clinics within the University of Pennsylvania Health System. Patients who come to the clinic with cold-like symptoms (runny nose, cough) will be offered the test. If the patient agrees to the test, their clinician will use a swab to take a small sample of fluid from their nose. This swab will then be tested within the POC device and results will be available within 15 minutes.
The results of this sample will be shared with the patient, and their clinician can use the results to help decide the most appropriate medical treatment for the patient.
Patients who agree to take the test will be asked to answer a short survey about the test and their experience. Clinicians will also be surveyed to share their thoughts with using the test in their clinics. Focus groups of practice staff and clinicians will also be conducted to understand any potential challenges for using this test in practice.
Results from the tests and the surveys will help researchers understand the value of the test to support antibiotic stewardship efforts in primary care clinic settings.
Read the detailed description
Point of care (POC) testing for respiratory viral pathogens has been proposed as a potential tool for use in antibiotic stewardship in primary care, particularly with reducing diagnostic uncertainty and supporting providers in communication about upper respiratory symptom etiology. However, there are limited data to support their widespread use. The research team propose to conduct a study that seeks to understand the role of POC respiratory pathogen testing on antibiotic prescribing in primary care practices. The research team plan to use qualitative methods, including focus groups and surveys of primary care clinicians to understand provider perceptions of POC respiratory pathogen testing (part 1). The research team will then perform a pragmatic, stepped-wedge, cluster randomized trial in 4-8 primary care practices to study the impact of implementation of the POC respiratory pathogen testing, using the Spotfire R panel, on antibiotic prescribing (part 2). The results from part 1 of the study will be used to optimize implementation in part 2 of the study. The research team will also assess several secondary outcomes in part 2, including antiviral prescribing, healthcare utilization, and patient and provider perceptions of the use of POC respiratory pathogen testing.
- Conditions
- Upper Respiratory Infection
- Being tested
- Clinician Survey, Focus Group, Biofire Spotfire Respiratory (R) panel, Patient Survey
- Keywords
- upper respiratory infections, primary care clinics, point of care testing, antibiotic stewardship
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician SurveyBehavioural
At the conclusion of the intervention period, practice stakeholders, including survey providers and practice managers in the intervention sites will be surveyed to identify their degree of satisfaction with the intervention and suggestions for improvement.
Focus GroupBehavioural
Prior to installing the device in each primary care practice, trained moderators will conduct focus groups with clinicians and practice staff to to elicit provider perceptions of POC testing for respiratory pathogens, including feasibility and acceptability of integration of testing into routine workflows.
Biofire Spotfire Respiratory (R) panelDiagnostic test
Eligible patients will be offered testing with the BioFire Spotfire Respiratory (R) Panel, which is an FDA-cleared, CLIA waived test. This 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 (NP) swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19. This testing will be made available in participating practices along with clinical guidance about use and interpretation. Clinicians will administer the tests to patients who agree to be tested. Results will be shared with patients, who can discuss the results with their clinicians. Clinicians can use the test results to guide their treatment decisions.
Patient SurveyBehavioural
During the intervention period, patients who undergo POC RPP testing will be surveyed soon after their visit to elicit their opinions about the test.
| Study group | Role | What they receive |
|---|---|---|
| Clinicians/practice staff | Other | Clinicians will be the target for the intervention that will include provision of the POC RPP (Point of Care Respiratory Pathogen Panel) test as well as clinical guidance on use and interpretation. Clinicians will also be included in focus groups and surveys, and other administrative practice staff will also be included in focus groups. All clinicians/staff practicing at one of the included practices will be eligible for inclusion Receives: Behavioral: Clinician Survey; Behavioral: Focus Group; Diagnostic Test: Biofire Spotfire Respiratory (R) panel |
| Patients | Other | All adult patients (age >=18 years) at one of the included primary care practices seen for an upper respiratory infection or symptom will be included in the primary study analysis, as identified by ICD-10 code (from baseline and intervention periods). Patients with ICD-10 codes for other bacterial infections at the same encounter will be excluded (e.g., skin and soft tissue infection) from the analysis. During the intervention period, adult patients with symptoms potentially suggestive of an upper respiratory infection will be eligible for use of the POC RPP test. Receives: Diagnostic Test: Biofire Spotfire Respiratory (R) panel; Behavioral: Patient Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic prescription at index visit
Proportion of patients with an antibiotic prescribed at the index visit
Measured: From participant enrollment to end of index visit
Secondary outcomes (9)
Provider attitudes and perceptions toward point of care respiratory pathogen testing
Attitudes and perceptions reported by providers on the "PROTECT Clinician Survey" instrument
Measured: Two months following completion of study intervention
Patient attitudes and perceptions toward point of care respiratory pathogen testing
Attitudes and perceptions reported by patients on the "PROTECT Patient Survey" instrument
Measured: From participant enrollment to two weeks after index visit
Antiviral prescription at index visit
Proportion of patients with an antiviral prescribed at the index visit
Measured: From participant enrollment to end of index visit
Antibiotic prescription at index visit for specific subgroups, including patients with specific diagnoses (sinusitis, acute bronchitis, acute pharyngitis) and patients with ICD-10 codes for diagnoses for which an antibiotic is typically not warranted
Proportion of patients with an antibiotic prescribed at the index visit within specific subgroups, including patients with sinusitis, acute bronchitis, acute pharyngitis, and patients with diagnoses for which an antibiotic is not typically warranted
Measured: From participant enrollment to end of index visit
Healthcare utilization, to include: 1. Follow up visits within 14 days after the index visit 2. Follow up telephone calls and messages within 14 days after the index visit 3. Antibiotic or antiviral prescriptions within 14 days after the index visit
Proportion of patients with 1) follow up visits; 2) follow up telephone calls or messages; 3) antibiotic prescribed; 4) antiviral prescribed within 14 days following the index visit
Measured: From participant enrollment to 14 days after index visit
Test utilization, to include use of Spotfire R panel
Proportion of patients who underwent POC RPP (Point of Care Respiratory Pathogen Panel) testing at the index visit
Measured: From participant enrollment to 14 days after index visit
Test utilization, to include laboratory-based respiratory pathogen testing
Proportion of patients who underwent testing for respiratory viruses using laboratory-based testing at the index visit
Measured: From participant enrollment to 14 days after index visit
Test utilization, to include Group A streptococcal testing
Proportion of patients who underwent testing for group A streptococcus at the index visit
Measured: From participant enrollment to 14 days after index visit
Test utilization, to include chest imaging
Proportion of patients ordered for chest imaging at the index visit
Measured: From participant enrollment to 14 days after index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Feb 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Dutcher, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765135
- Sponsor's protocol ID
- 856091
- Acronym
- PROTECT
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Respiratory Pathogen Testing for Antibiotic Stewardship in Primary Care
- ClinicalTrials.gov ID
- NCT06765135
- Acronym / sponsor ID
- PROTECT / 856091
- Conditions
- Upper Respiratory Infection
- Keywords
- upper respiratory infections, primary care clinics, point of care testing, antibiotic stewardship
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to understand the use of point of care (POC) testing devices in primary care offices to help clinicians diagnose and appropriately treat patients who have symptoms of upper respiratory infections (URIs).
The study will use the BIOFIRE® SPOTFIRE® Respiratory (R) Panel testing device, which is FDA-cleared and CLIA-Waived. This panel can identify up to 15 different viruses and bacteria that can cause URIs.
These POC devices will be installed in primary care clinics within the University of Pennsylvania Health System. Patients who come to the clinic with cold-like symptoms (runny nose, cough) will be offered the test. If the patient agrees to the test, their clinician will use a swab to take a small sample of fluid from their nose. This swab will then be tested within the POC device and results will be available within 15 minutes.
The results of this sample will be shared with the patient, and their clinician can use the results to help decide the most appropriate medical treatment for the patient.
Patients who agree to take the test will be asked to answer a short survey about the test and their experience. Clinicians will also be surveyed to share their thoughts with using the test in their clinics. Focus groups of practice staff and clinicians will also be conducted to understand any potential challenges for using this test in practice.
Results from the tests and the surveys will help researchers understand the value of the test to support antibiotic stewardship efforts in primary care clinic settings.
Detailed description
Point of care (POC) testing for respiratory viral pathogens has been proposed as a potential tool for use in antibiotic stewardship in primary care, particularly with reducing diagnostic uncertainty and supporting providers in communication about upper respiratory symptom etiology. However, there are limited data to support their widespread use. The research team propose to conduct a study that seeks to understand the role of POC respiratory pathogen testing on antibiotic prescribing in primary care practices. The research team plan to use qualitative methods, including focus groups and surveys of primary care clinicians to understand provider perceptions of POC respiratory pathogen testing (part 1). The research team will then perform a pragmatic, stepped-wedge, cluster randomized trial in 4-8 primary care practices to study the impact of implementation of the POC respiratory pathogen testing, using the Spotfire R panel, on antibiotic prescribing (part 2). The results from part 1 of the study will be used to optimize implementation in part 2 of the study. The research team will also assess several secondary outcomes in part 2, including antiviral prescribing, healthcare utilization, and patient and provider perceptions of the use of POC respiratory pathogen testing.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinicians/practice staff | Other | Behavioral: Clinician Survey, Behavioral: Focus Group, Diagnostic Test: Biofire Spotfire Respiratory (R) panelClinicians will be the target for the intervention that will include provision of the POC RPP (Point of Care Respiratory Pathogen Panel) test as well as clinical guidance on use and interpretation. Clinicians will also be included in focus groups and surveys, and other administrative practice staff will also be included in focus groups. All clinicians/staff practicing at one of the included practices will be eligible for inclusion |
| Patients | Other | Diagnostic Test: Biofire Spotfire Respiratory (R) panel, Behavioral: Patient SurveyAll adult patients (age >=18 years) at one of the included primary care practices seen for an upper respiratory infection or symptom will be included in the primary study analysis, as identified by ICD-10 code (from baseline and intervention periods). Patients with ICD-10 codes for other bacterial infections at the same encounter will be excluded (e.g., skin and soft tissue infection) from the analysis. During the intervention period, adult patients with symptoms potentially suggestive of an upper respiratory infection will be eligible for use of the POC RPP test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >=18 years
- Symptoms of an upper respiratory infection to include: cough, rhinorrhea, nasal congestion, fever, sore throat, ear pain/fullness, sinus pain
Key exclusion criteria (2 listed)
- Age < 18 years of age
- No relevant upper respiratory symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician SurveyAt the conclusion of the intervention period, practice stakeholders, including survey providers and practice managers in the intervention sites will be surveyed to identify their degree of satisfaction with the intervention and suggestions for improvement. | Behavioural | Clinicians/practice staff |
| Focus GroupPrior to installing the device in each primary care practice, trained moderators will conduct focus groups with clinicians and practice staff to to elicit provider perceptions of POC testing for respiratory pathogens, including feasibility and acceptability of integration of testing into routine workflows. | Behavioural | Clinicians/practice staff |
| Biofire Spotfire Respiratory (R) panelEligible patients will be offered testing with the BioFire Spotfire Respiratory (R) Panel, which is an FDA-cleared, CLIA waived test. This 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 (NP) swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19. This testing will be made available in participating practices along with clinical guidance about use and interpretation. Clinicians will administer the tests to patients who agree to be tested. Results will be shared with patients, who can discuss the results with their clinicians. Clinicians can use the test results to guide their treatment decisions. | Diagnostic test | Clinicians/practice staff, Patients |
| Patient SurveyDuring the intervention period, patients who undergo POC RPP testing will be surveyed soon after their visit to elicit their opinions about the test. | Behavioural | Patients |
Primary outcome
Antibiotic prescription at index visit
Time frame: From participant enrollment to end of index visit
Proportion of patients with an antibiotic prescribed at the index visit
9 secondary outcomes
Provider attitudes and perceptions toward point of care respiratory pathogen testing
Time frame: Two months following completion of study intervention
Patient attitudes and perceptions toward point of care respiratory pathogen testing
Time frame: From participant enrollment to two weeks after index visit
Antiviral prescription at index visit
Time frame: From participant enrollment to end of index visit
Antibiotic prescription at index visit for specific subgroups, including patients with specific diagnoses (sinusitis, acute bronchitis, acute pharyngitis) and patients with ICD-10 codes for diagnoses for which an antibiotic is typically not warranted
Time frame: From participant enrollment to end of index visit
Healthcare utilization, to include: 1. Follow up visits within 14 days after the index visit 2. Follow up telephone calls and messages within 14 days after the index visit 3. Antibiotic or antiviral prescriptions within 14 days after the index visit
Time frame: From participant enrollment to 14 days after index visit
Test utilization, to include use of Spotfire R panel
Time frame: From participant enrollment to 14 days after index visit
Test utilization, to include laboratory-based respiratory pathogen testing
Time frame: From participant enrollment to 14 days after index visit
Test utilization, to include Group A streptococcal testing
Time frame: From participant enrollment to 14 days after index visit
Test utilization, to include chest imaging
Time frame: From participant enrollment to 14 days after index visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician Survey, Focus Group and Biofire Spotfire Respiratory (R) panel in people with Upper Respiratory Infection, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic prescription at index visit (time frame: From participant enrollment to end of index visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.