Common Cold, Influenza, Human, Respiratory Tract Infections
Conditions
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
Brief 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).
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.
Interventions
DEVICERapid 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.
Sponsors
BioFire Diagnostics, LLC
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 101 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Neonates * Prisoners * Employees of UC Davis/Students of the Principal Investigator or Co-Principal Investigator * Non-English, non-Spanish speaking patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED | Day 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis | Day 0 | — |
| Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription | Day 0 | Composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients |
| Proportion of Patients Discharged Home From the ED Versus Hospital Admission | Day 0 | — |
| Proportion of Patients With a Respiratory Pathogen Identified | Day 0 | Any respiratory pathogen detected by the FilmArray Respiratory Panel test or other diagnostic test ordered by the physician |
| 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 | — |
| Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days | 30 days | — |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from rapid care and main adult and pediatric ED areas between December 2016 and April 2018.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 93 |
| 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. | 98 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Rapid Respiratory Pathogen Test Arm | Usual Care Control Arm | Total |
|---|---|---|---|
| Age, Customized Adults (18 y or older) | 61 Participants | 59 Participants | 120 Participants |
| Age, Customized Pediatric (1-17 y) | 32 Participants | 39 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 32 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 66 Participants | 132 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 17 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 20 Participants | 29 Participants | 49 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 43 Participants | 44 Participants | 87 Participants |
| Region of Enrollment United States | 93 participants | 98 participants | 191 participants |
| Sex: Female, Male Female | 55 Participants | 55 Participants | 110 Participants |
| Sex: Female, Male Male | 38 Participants | 43 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 93 | 0 / 98 |
| other Total, other adverse events | 0 / 93 | 0 / 98 |
| serious Total, serious adverse events | 0 / 93 | 0 / 98 |
Outcome results
Primary
Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Respiratory Pathogen Test Arm | Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED | 20 Participants |
| Usual Care Control Arm | Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED | 33 Participants |
Secondary
Median Length of ED Stay
Time frame: Day 0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rapid Respiratory Pathogen Test Arm | Median Length of ED Stay | 4.7 hours |
| Usual Care Control Arm | Median Length of ED Stay | 5.0 hours |
Secondary
Median Length of Hospital Stay
Time frame: 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rapid Respiratory Pathogen Test Arm | Median Length of Hospital Stay | 71.2 hours |
| Usual Care Control Arm | Median Length of Hospital Stay | 54.93 hours |
Secondary
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
Population: Analysis limited to patients with influenza test and positive influenza result.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Respiratory Pathogen Test Arm | Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only) | 7 Participants |
| Usual Care Control Arm | Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only) | 3 Participants |
Secondary
Proportion of Patients Discharged Home From the ED Versus Hospital Admission
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Respiratory Pathogen Test Arm | Proportion of Patients Discharged Home From the ED Versus Hospital Admission | 69 Participants |
| Usual Care Control Arm | Proportion of Patients Discharged Home From the ED Versus Hospital Admission | 66 Participants |
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
Time frame: Day 0
Population: Analysis limited to population receiving an Influenza test defining positive or negative laboratory confirmed Influenza status.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Respiratory Pathogen Test Arm | Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription | 73 Participants |
| Usual Care Control Arm | Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription | 32 Participants |
Secondary
Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Respiratory Pathogen Test Arm | Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis | 24 Participants |
| Usual Care Control Arm | Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis | 8 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Respiratory Pathogen Test Arm | Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days | 31 Participants |
| Usual Care Control Arm | Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days | 38 Participants |
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
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid Respiratory Pathogen Test Arm | Proportion of Patients With a Respiratory Pathogen Identified | 61 Participants |
| Usual Care Control Arm | Proportion of Patients With a Respiratory Pathogen Identified | 20 Participants |