Respiratory Tract InfectionsURIDxEDNCT02957136
Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department
A study testing Rapid respiratory pathogen nucleic acid amplification test in people with Respiratory Tract Infections and Influenza, Human, run by University of California, Davis at 1 site in United States.
Trial summary
This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI). Read more about this study
- Who is it for?
- Ages 1 year to 101 years
- Conditions the study is for
- Respiratory Tract Infections, Influenza, Human, Common Cold
- What is being tested?
- Rapid respiratory pathogen nucleic acid amplification test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2016to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 101 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- University of California, Davis (UC Davis) Emergency Department patients evaluated for influenza like illness and/or upper respiratory infection by an ED physician who consent and agree to have a nasopharyngeal swab collected for the study
- English speaking or Spanish speaking patients
Who cannot join
- Neonates
- Prisoners
- Employees of UC Davis/Students of the Principal Investigator or Co-Principal Investigator
- Non-English, non-Spanish speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Randomized Clinical Trial of Multi-respiratory Pathogen Testing Versus Usual Care in Emergency Department (ED) Patients With Upper Respiratory Symptoms
This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI).
Read the detailed description
This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI). The intervention is a rapid, multi-respiratory pathogen nucleic acid amplification panel test (FilmArray Respiratory Panel; BioFire Diagnostics, LLC) with clinical result reporting within two hours of sample collection. Randomization is at the individual patient level. Intervention patients will receive usual care plus the rapid multi-respiratory pathogen test. Control patients will receive physician-directed usual care without the rapid, multi-respiratory pathogen test, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for multiple respiratory pathogens at an off-site laboratory. The primary outcome is antibiotic administration or prescription during the initial ED episode of care. The investigators primary hypothesis is that rapid multi-respiratory pathogen testing will be associated with a ≥15% reduction in antibiotic use in intervention patients, relative to control patients (usual care). The investigators secondary outcome is administration or prescription of antivirals during the initial ED episode of care. The investigators secondary hypothesis is that rapid multi-respiratory pathogen testing will improve anti-influenza medication use in intervention patients (composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients), relative to control patients receiving usual care alone.
- Conditions
- Respiratory Tract Infections, Influenza, Human, Common Cold
- Being tested
- Rapid respiratory pathogen nucleic acid amplification test
- Keywords
- Respiratory Tract Infections, Influenza, Human, Common Cold, Viral Infection, Pathology, Molecular, Molecular Diagnostics, Diagnostic Testing, Clinical Microbiology, Polymerase Chain Reaction, Antibiotic Stewardship, Antimicrobial Use, Emergency Department, Emergency Room
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human, Common Cold, Virus Diseases, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid respiratory pathogen nucleic acid amplification testDevice
Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.
| Study group | Role | What they receive |
|---|---|---|
| Rapid respiratory pathogen test arm | Experimental | ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Receives: Device: Rapid respiratory pathogen nucleic acid amplification test |
| Usual care control arm | No intervention | ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED
Measured: Day 0
Secondary outcomes (8)
Proportion of Patients With a Respiratory Pathogen Identified
Any respiratory pathogen detected by the FilmArray Respiratory Panel test or other diagnostic test ordered by the physician
Measured: Day 0
Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis
Measured: Day 0
Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription
Composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients
Measured: Day 0
Proportion of Patients Discharged Home From the ED Versus Hospital Admission
Measured: Day 0
Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days
Measured: 30 days
Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only)
Measured: Day 0
Median Length of ED Stay
Measured: Day 0
Median Length of Hospital Stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start8 Dec 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- BioFire Diagnostics, LLC
- Responsible party
- Sponsor
- Investigators
- Christopher Polage, MD, MAS, Principal investigator, Duke UniversityLarissa May, MD, MSPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957136
- Sponsor's protocol ID
- 894097
- Acronym
- URIDxED
- Status last verified
- Apr 2021
- First submitted
- 31 Oct 2016
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
May L, Tatro G, Poltavskiy E, Mooso B, Hon S, Bang H, Polage C. Rapid Multiplex Testing for Upper Respiratory Pathogens in the Emergency Department: A Randomized Controlled Trial. Open Forum Infect Dis. 2019 Nov 5;6(12):ofz481. doi: 10.1093/ofid/ofz481. eCollection 2019 Dec.
PubMed 32128326
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Multi-respiratory Pathogen Testing Versus Usual Care in Emergency Department (ED) Patients With Upper Respiratory Symptoms
- ClinicalTrials.gov ID
- NCT02957136
- Acronym / sponsor ID
- URIDxED / 894097
- Conditions
- Respiratory Tract Infections, Influenza, Human, Common Cold
- Keywords
- Respiratory Tract Infections, Influenza, Human, Common Cold, Viral Infection, Pathology, Molecular, Molecular Diagnostics, Diagnostic Testing, Clinical Microbiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- BioFire Diagnostics, LLC
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI).
Detailed description
This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI). The intervention is a rapid, multi-respiratory pathogen nucleic acid amplification panel test (FilmArray Respiratory Panel; BioFire Diagnostics, LLC) with clinical result reporting within two hours of sample collection. Randomization is at the individual patient level. Intervention patients will receive usual care plus the rapid multi-respiratory pathogen test. Control patients will receive physician-directed usual care without the rapid, multi-respiratory pathogen test, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for multiple respiratory pathogens at an off-site laboratory. The primary outcome is antibiotic administration or prescription during the initial ED episode of care. The investigators primary hypothesis is that rapid multi-respiratory pathogen testing will be associated with a ≥15% reduction in antibiotic use in intervention patients, relative to control patients (usual care). The investigators secondary outcome is administration or prescription of antivirals during the initial ED episode of care. The investigators secondary hypothesis is that rapid multi-respiratory pathogen testing will improve anti-influenza medication use in intervention patients (composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients), relative to control patients receiving usual care alone.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid respiratory pathogen test arm | Experimental | Device: Rapid respiratory pathogen nucleic acid amplification testED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. |
| Usual care control arm | No intervention | –ED patients in this arm will receive clinician-directed standard of care, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for respiratory pathogens at off-site laboratory. |
Who may qualify
- Ages
- 1 year to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- University of California, Davis (UC Davis) Emergency Department patients evaluated for influenza like illness and/or upper respiratory infection by an ED physician who consent and agree to have a nasopharyngeal swab collected for the study
- English speaking or Spanish speaking patients
Key exclusion criteria (4 listed)
- Neonates
- Prisoners
- Employees of UC Davis/Students of the Principal Investigator or Co-Principal Investigator
- Non-English, non-Spanish speaking patients
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 |
|---|---|---|
| Rapid respiratory pathogen nucleic acid amplification testPatients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel. | Device | Rapid respiratory pathogen test arm |
Primary outcome
Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED
Time frame: Day 0
8 secondary outcomes
Proportion of Patients With a Respiratory Pathogen Identified
Time frame: Day 0
Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis
Time frame: Day 0
Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription
Time frame: Day 0
Proportion of Patients Discharged Home From the ED Versus Hospital Admission
Time frame: Day 0
Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days
Time frame: 30 days
Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only)
Time frame: Day 0
Median Length of ED Stay
Time frame: Day 0
Median Length of Hospital Stay
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32128326May L, Tatro G, Poltavskiy E, Mooso B, Hon S, Bang H, Polage C. Rapid Multiplex Testing for Upper Respiratory Pathogens in the Emergency Department: A Randomized Controlled Trial. Open Forum Infect Dis. 2019 Nov 5;6(12):ofz481. doi: 10.1093/ofid/ofz481. eCollection 2019 Dec.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Christopher Polage, MD, MAS principal investigator
Duke University
Larissa May, MD, MSPH principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid respiratory pathogen nucleic acid amplification test in people with Respiratory Tract Infections and Influenza, Human, run by University of California, Davis 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 4 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: finished, as of the sponsor's last update on 19 May 2021. 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?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02957136, which also lists 1 linked publication.
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 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.