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| Name | Class |
|---|---|
| BioFire Diagnostics, LLC | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid respiratory pathogen test arm | Experimental | ED 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid respiratory pathogen nucleic acid amplification test | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0 |
| Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Polage, MD, MAS | Duke University | Principal Investigator |
| Larissa May, MD, MSPH | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32128326 | Derived | 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. |
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Participants were recruited from rapid care and main adult and pediatric ED areas between December 2016 and April 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rapid Respiratory Pathogen Test Arm | ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: 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. |
| FG001 | Usual Care Control Arm | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rapid Respiratory Pathogen Test Arm | ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED | Posted | Count of Participants | Participants | Day 0 |
|
30 days
Collected all-cause mortality at 30 days, hospitalization (disposition from initial ED study visit), 30-day revisit to ED (all, respiratory illness-related, nonrespiratory illness related)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rapid Respiratory Pathogen Test Arm | ED patients in this arm will receive a rapid respiratory pathogen nucleic acid amplification test plus usual care. Rapid respiratory pathogen nucleic acid amplification test: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Polage | Duke University Health System | 919-668-5008 | christopher.polage@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2018 | Dec 17, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2018 | Dec 17, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007251 | Influenza, Human |
| D003139 | Common Cold |
| D014777 | Virus Diseases |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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|
| 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 | Day 0 |
| Proportion of Patients Discharged Home From the ED Versus Hospital Admission | Day 0 |
| Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days | 30 days |
| Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only) | Day 0 |
| Median Length of ED Stay | Day 0 |
| Median Length of Hospital Stay | 30 days |
| BG001 | Usual Care Control Arm | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Usual Care Control Arm | 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. |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Day 0 |
|
|
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| Secondary | Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis | Posted | Count of Participants | Participants | Day 0 |
|
|
|
| Secondary | 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 | Analysis limited to population receiving an Influenza test defining positive or negative laboratory confirmed Influenza status. | Posted | Count of Participants | Participants | Day 0 |
|
|
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| Secondary | Proportion of Patients Discharged Home From the ED Versus Hospital Admission | Posted | Count of Participants | Participants | Day 0 |
|
|
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| Secondary | Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only) | Analysis limited to patients with influenza test and positive influenza result. | Posted | Count of Participants | Participants | Day 0 |
|
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| Secondary | Median Length of ED Stay | Posted | Median | Full Range | hours | Day 0 |
|
|
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| Secondary | Median Length of Hospital Stay | Posted | Median | Full Range | hours | 30 days |
|
|
|
| 1 |
| 93 |
| 0 |
| 93 |
| 0 |
| 93 |
| EG001 | Usual Care Control Arm | 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. | 0 | 98 | 0 | 98 | 0 | 98 |
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| D010850 |
| Picornaviridae Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |