An interventional study of BioFire® Respiratory Panel 2.1-EZ in Viral Infection, Acute Respiratory Infection and Upper Resp Tract Infection, sponsored by Andrew Meltzer. Completed at 2 sites in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Andrew Meltzer · Not applicable, Interventional, and Diagnostic
Rapid diagnosis and precise treatment have become possible with multiplex polymerase chain reaction (PCR) panels that can identify a variety of causative agents of acute respiratory illnesses such as bacterial and viral infections in one urgent care visit. While real-time PCR is currently used as a standard for diagnosing acute respiratory illnesses such as influenza due to its high sensitivity and specificity, it typically takes several hours for results which is unfavorable in the urgent care setting. Highly sensitive and rapid random-access PCR tests provide the sensitivity and specificity needed to both rapidly and accurately diagnose acute respiratory illnesses. Similar PCR panels have been used in previous research for the diagnosis of gastrointestinal illnesses in the emergency department and point-of-care testing for hospitalized adults presenting with acute respiratory illness. In this study, the investigators aim to determine if a rapid multiplex PCR test for urgent care patients with symptomatic upper respiratory infections can improve patient and provider-reported outcomes. This study utilizes the Biofire® FilmArray Panel (RP2.1-EZ) which in previous studies has been shown to be highly effective in diagnosing acute respiratory illnesses.
Research assistants in the IPCs will screen for possible participants by searching the electronic health record for complaints and/or symptoms of respiratory illness. Patients who screen eligible will be approached about potential interest, review inclusion and exclusion criteria, and obtain informed consent. All consented patients will be given a study ID and recorded in enrollment log. Patients who consent will be randomized to one of the two groups: BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ; EXP) versus standard care (SC). The RP2.1-EZ panel is designed to test for a variety of bacterial and/or viral causes for illness whereas standard care procedures are essentially yes/no to patient having SARS-COV-2. Both groups will receive a nasal swab, however, the EXP group will receive the BioFire RP2.1-EZ panel, and the SC group will receive the standard nasal swab used in the IPCs. As the RP2.1-EZ panel includes SARS-COV-2, patients in the EXP group need not receive two separate nasal swabs. Nasal swabs will be performed for both groups, ideally during triage, however, the sample may be collected any time during the visit, by staff trained by BioFire Diagnostics LLC. After the nasal swab is collected, it will be either sent to LabCorp (SC) or tested on site (EXP). On site testing of samples for EXP arm will occur in the same IPC room where rapid COVID-19 tests are tested. EXP panel results should be processed within 45 minutes to 1 hour but will be communicated to patient at COB (see below). Results will be communicated to both the patient and the health care provider as soon as possible, typically on the same day as enrollment. The research team will explain the results using a standarization script written by medical professionals. If patients have further questions, they will be referred to their healthcare provider. The usage of the RP EZ-2.1 Panel will guide the managemnet of providers in the following ways: more focused advice on time to isolate and/or quartine for patients, focused advice regarding infectivity, identifying the natural course of disease faster, guiding anti-biotic decisions for providers, and helping providers identify potential anti-viral therapy in a faster manner.
Patient data will be collected regarding demographics (Form D), comorbidities (Form D), nature of current symptoms (Form D), vaccination status (Form D), quality of life measures (Form E), vital signs at triage (Form F), CPT and ICD-10 codes (Form D), and travel history (Form D). This will be collected after the nasal swab is collected before the patient leaves the clinic. Patients will complete this form on a password protected iPad through secure REDCAP survey in a private, patient room. Patients will receive their results at the end of the day via follow up phone call by the research assistants (RAs) if randomized to the EXP group. If randomized to the SC group, patients will receive their results within 24-72 hours, dependent on turn around time at LabCorp. RAs will be providing results to both patients and providers. Providers can opt to complete a brief questionnaire (i.e., five minutes or less) regarding how their course of treatment was affected by the results. RAs will call patients to complete a brief satisfaction survey (15 minutes) with their results (if available) and uploaded results can be found in patient's electronic health record. Standardized scripts written by medical professionals will be used to provide diagnostic feedback for both patient groups via phone. Research assistants will provide diagnostic feedback to the providers in person for the EXP group. Clinician ordered testing (if any) can occur at any time and will be reported per usual protocol. If testing comes back positive for a bacterial/viral pathogen for EXP arm or SARS-COV-2 for SC arm, participants be referred to their health care provider if they want to seek further treatment or have questions about results. This is not inconsistent with the standard practices now happening at the IPCs. The study coordinator or trained research assistants will follow up with all enrolled patients at 7 business days to evaluate the course of symptoms, assess patient satisfaction, and to assess other relevant medical information.
927 studies on the registry are indexed under Virus Diseases; 112 are open to participants now.
This study's enrollment of 360 is above the median of 100 across 614 interventional studies indexed under Virus Diseases.
Browse Virus Diseases studies →Andrew Meltzer is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
Diagnostic Test: BioFire® Respiratory Panel 2.1-EZ
Standard care procedures are essentially yes/no to patient having SARS-COV-2, the SC group will receive the standard nasal swab used in the IPCs.
BioFire RP2.1-EZ Panel uses a syndromic approach to quickly identify SARS-CoV-2, along with 18 additional viral and bacterial pathogens in patients suspected of SARS-CoV-2. This PCR test provides results in about 45 minutes.
Satisfaction With Time to Receive Result
Based on any results you have received from today's tests, are you satisfied in the time it has taken to communicate the results?
Time frame: Day of enrollment
Confidence in Testing
Based on testing today, do you feel confident that you know what is causing your illness?
Time frame: Day of Enrollment
Intention to Self Isolate
Based on the testing you received today, are you planning to isolate from friends and family?
Time frame: Day of enrollment
Plan to Seek Care From Another Doctor or Healthcare Facility
Will you seek out additional diagnostic testing or care from another doctor or healthcare facility?
Time frame: Day of enrollment
Will Patient Plan for Work Absence
Based on test results received today, will you plan to miss work?
Time frame: Day of enrollment
Did the Time to Receive Test Results Affect You and Prevent You From Doing Activities You Normally Would do?
Did the time to receive test results affect you and prevent you from doing activities you normally would do?
Time frame: Day 7 after enrollment
I am Satisfied With the Time it Took to Receive the Test Results.
Time frame: Day 7 after enrollment
Were Antibiotics Prescribed as Part of the IPC Visit for Respiratory Illness?
Practitioner-Centered Results
Time frame: Day of Enrollment
Confidence in Patient's Cause of Illness
How confident are you that you know what is causing your patient's illness?
Time frame: Day of Enrollment
| Milestone | BioFire® Respiratory Panel 2.1-EZ | Standard of Care |
|---|---|---|
| Started | 205 | 155 |
| Completed | 205 | 155 |
| Not completed | 0 | 0 |
Based on any results you have received from today's tests, are you satisfied in the time it has taken to communicate the results?
| participants | BioFire® Respiratory Panel 2.1-EZ | Standard of Care |
|---|---|---|
| Yes | 180 | 53 |
| No | 3 | 72 |
Based on testing today, do you feel confident that you know what is causing your illness?
| Participants | BioFire® Respiratory Panel 2.1-EZ | Standard of Care |
|---|---|---|
| Yes | 111 | 37 |
| No | 43 | 57 |
| Unsure | 29 | 30 |
| Missing | 0 | 1 |
Based on the testing you received today, are you planning to isolate from friends and family?
| Participants | BioFire® Respiratory Panel 2.1-EZ | Standard of Care |
|---|---|---|
| Yes | 74 | 50 |
| No | 98 | 45 |
| Unsure | 9 | 27 |
| Not Applicable | 2 | 3 |
Will you seek out additional diagnostic testing or care from another doctor or healthcare facility?
| Participants | BioFire® Respiratory Panel 2.1-EZ | Standard of Care |
|---|---|---|
| Yes | 30 | 17 |
| No | 134 | 80 |
| Unsure | 19 | 28 |
Based on test results received today, will you plan to miss work?
| Participants | BioFire® Respiratory Panel 2.1-EZ | Standard of Care |
|---|---|---|
| Yes | 62 | 60 |
| No | 78 | 42 |
| Not applicable | 43 | 23 |
Did the time to receive test results affect you and prevent you from doing activities you normally would do?
| participants | BioFire® Respiratory Panel 2.1-EZ | Standard of Care |
|---|---|---|
| Yes | 26 | 38 |
| No | 130 | 86 |
| Participants | BioFire® Respiratory Panel 2.1-EZ | Standard of Care |
|---|---|---|
| Strongly agree/Agree | 145 | 73 |
| Neither agree or disagree | 7 | 16 |
| Strongly disagree/Disagree | 4 | 33 |
Practitioner-Centered Results
| Participants | BioFire® Respiratory Panel 2.1-EZ | Standard of Care |
|---|---|---|
| Yes | 52 | 27 |
| No | 103 | 77 |
How confident are you that you know what is causing your patient's illness?
| Participants | BioFire® Respiratory Panel 2.1-EZ | Standard of Care |
|---|---|---|
| Less confident | 10 | 15 |
| No effect | 20 | 41 |
| More satisfied | 125 | 48 |
Collected over All-cause mortality, Serious Adverse Events, and Other Adverse Events were monitored/assessed at Day 0 and Day 7. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BioFire® Respiratory Panel 2.1-EZ | 0/205 (0%) | 0/205 (0%) | 0/205 (0%) |
| Standard of Care | 0/155 (0%) | 0/155 (0%) | 0/155 (0%) |
| Age, Customized(years) | BioFire® Respiratory Panel 2.1-EZ | Standard of Care | Total |
|---|---|---|---|
| Age (median age, years) | 34 (7 to 80) | 34 (7 to 89) | 34 (7 to 89) |
| Sex: Female, Male(Participants) | BioFire® Respiratory Panel 2.1-EZ | Standard of Care | Total |
|---|---|---|---|
| Female | 138 | 94 | 232 |
| Male | 67 | 61 | 128 |
| Ethnicity (NIH/OMB)(Participants) | BioFire® Respiratory Panel 2.1-EZ | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 19 | 10 | 29 |
| Not Hispanic or Latino | 184 | 145 | 329 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | BioFire® Respiratory Panel 2.1-EZ | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 13 | 7 | 20 |
| Native Hawaiian or Other Pacific Islander | 11 | 5 | 16 |
| Black or African American | 81 | 58 | 139 |
| White | 100 | 83 | 183 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
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