Trial Outcomes & Findings for Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department (NCT NCT02957136)
NCT ID: NCT02957136
Last Updated: 2021-05-19
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
194 participants
Primary outcome timeframe
Day 0
Results posted on
2021-05-19
Participant Flow
Participants were recruited from rapid care and main adult and pediatric ED areas between December 2016 and April 2018.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
99
|
|
Overall Study
COMPLETED
|
93
|
98
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department
Baseline characteristics by cohort
| Measure |
Rapid Respiratory Pathogen Test Arm
n=93 Participants
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.
|
Usual Care Control Arm
n=98 Participants
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.
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Pediatric (1-17 y)
|
32 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Customized
Adults (18 y or older)
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
98 participants
n=7 Participants
|
191 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0Outcome measures
| Measure |
Rapid Respiratory Pathogen Test Arm
n=93 Participants
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.
|
Usual Care Control Arm
n=98 Participants
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.
|
|---|---|---|
|
Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED
|
20 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Day 0Any respiratory pathogen detected by the FilmArray Respiratory Panel test or other diagnostic test ordered by the physician
Outcome measures
| Measure |
Rapid Respiratory Pathogen Test Arm
n=93 Participants
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.
|
Usual Care Control Arm
n=98 Participants
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.
|
|---|---|---|
|
Proportion of Patients With a Respiratory Pathogen Identified
|
61 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 0Outcome measures
| Measure |
Rapid Respiratory Pathogen Test Arm
n=93 Participants
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.
|
Usual Care Control Arm
n=98 Participants
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.
|
|---|---|---|
|
Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis
|
24 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 0Population: Analysis limited to population receiving an Influenza test defining positive or negative laboratory confirmed Influenza status.
Composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients
Outcome measures
| Measure |
Rapid Respiratory Pathogen Test Arm
n=93 Participants
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.
|
Usual Care Control Arm
n=37 Participants
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.
|
|---|---|---|
|
Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription
|
73 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Day 0Outcome measures
| Measure |
Rapid Respiratory Pathogen Test Arm
n=93 Participants
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.
|
Usual Care Control Arm
n=98 Participants
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.
|
|---|---|---|
|
Proportion of Patients Discharged Home From the ED Versus Hospital Admission
|
69 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Rapid Respiratory Pathogen Test Arm
n=93 Participants
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.
|
Usual Care Control Arm
n=98 Participants
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.
|
|---|---|---|
|
Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days
|
31 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Day 0Population: Analysis limited to patients with influenza test and positive influenza result.
Outcome measures
| Measure |
Rapid Respiratory Pathogen Test Arm
n=24 Participants
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.
|
Usual Care Control Arm
n=8 Participants
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.
|
|---|---|---|
|
Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only)
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 0Outcome measures
| Measure |
Rapid Respiratory Pathogen Test Arm
n=93 Participants
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.
|
Usual Care Control Arm
n=98 Participants
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.
|
|---|---|---|
|
Median Length of ED Stay
|
4.7 hours
Interval 1.5 to 15.2
|
5.0 hours
Interval 1.6 to 13.1
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Rapid Respiratory Pathogen Test Arm
n=20 Participants
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.
|
Usual Care Control Arm
n=27 Participants
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.
|
|---|---|---|
|
Median Length of Hospital Stay
|
71.2 hours
Interval 23.8 to 441.0
|
54.93 hours
Interval 5.4 to 343.0
|
Adverse Events
Rapid Respiratory Pathogen Test Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place