Trial Outcomes & Findings for Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway (NCT NCT05467007)
NCT ID: NCT05467007
Last Updated: 2024-09-19
Results Overview
Based on any results you have received from today's tests, are you satisfied in the time it has taken to communicate the results?
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
360 participants
Primary outcome timeframe
Day of enrollment
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
BioFire® Respiratory Panel 2.1-EZ
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
BioFire® Respiratory Panel 2.1-EZ: 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.
|
Standard of Care
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.
|
|---|---|---|
|
Overall Study
STARTED
|
205
|
155
|
|
Overall Study
COMPLETED
|
205
|
155
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Urgent Care Management of Respiratory Illness Enabled With Novel Testing Pathway
Baseline characteristics by cohort
| Measure |
BioFire® Respiratory Panel 2.1-EZ
n=205 Participants
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
BioFire® Respiratory Panel 2.1-EZ: 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.
|
Standard of Care
n=155 Participants
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.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (median age, years)
|
34 years
n=5 Participants
|
34 years
n=7 Participants
|
34 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
184 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
329 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
81 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of enrollmentBased on any results you have received from today's tests, are you satisfied in the time it has taken to communicate the results?
Outcome measures
| Measure |
BioFire® Respiratory Panel 2.1-EZ
n=183 Participants
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
BioFire® Respiratory Panel 2.1-EZ: 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.
|
Standard of Care
n=125 Participants
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.
|
|---|---|---|
|
Satisfaction With Time to Receive Result
Yes
|
180 participants
|
53 participants
|
|
Satisfaction With Time to Receive Result
No
|
3 participants
|
72 participants
|
SECONDARY outcome
Timeframe: Day of EnrollmentBased on testing today, do you feel confident that you know what is causing your illness?
Outcome measures
| Measure |
BioFire® Respiratory Panel 2.1-EZ
n=183 Participants
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
BioFire® Respiratory Panel 2.1-EZ: 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.
|
Standard of Care
n=125 Participants
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.
|
|---|---|---|
|
Confidence in Testing
Yes
|
111 Participants
|
37 Participants
|
|
Confidence in Testing
No
|
43 Participants
|
57 Participants
|
|
Confidence in Testing
Unsure
|
29 Participants
|
30 Participants
|
|
Confidence in Testing
Missing
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day of enrollmentBased on the testing you received today, are you planning to isolate from friends and family?
Outcome measures
| Measure |
BioFire® Respiratory Panel 2.1-EZ
n=183 Participants
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
BioFire® Respiratory Panel 2.1-EZ: 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.
|
Standard of Care
n=125 Participants
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.
|
|---|---|---|
|
Intention to Self Isolate
Yes
|
74 Participants
|
50 Participants
|
|
Intention to Self Isolate
No
|
98 Participants
|
45 Participants
|
|
Intention to Self Isolate
Not Applicable
|
2 Participants
|
3 Participants
|
|
Intention to Self Isolate
Unsure
|
9 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Day of enrollmentWill you seek out additional diagnostic testing or care from another doctor or healthcare facility?
Outcome measures
| Measure |
BioFire® Respiratory Panel 2.1-EZ
n=183 Participants
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
BioFire® Respiratory Panel 2.1-EZ: 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.
|
Standard of Care
n=125 Participants
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.
|
|---|---|---|
|
Plan to Seek Care From Another Doctor or Healthcare Facility
Yes
|
30 Participants
|
17 Participants
|
|
Plan to Seek Care From Another Doctor or Healthcare Facility
No
|
134 Participants
|
80 Participants
|
|
Plan to Seek Care From Another Doctor or Healthcare Facility
Unsure
|
19 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Day of enrollmentBased on test results received today, will you plan to miss work?
Outcome measures
| Measure |
BioFire® Respiratory Panel 2.1-EZ
n=183 Participants
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
BioFire® Respiratory Panel 2.1-EZ: 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.
|
Standard of Care
n=125 Participants
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.
|
|---|---|---|
|
Will Patient Plan for Work Absence
Yes
|
62 Participants
|
60 Participants
|
|
Will Patient Plan for Work Absence
No
|
78 Participants
|
42 Participants
|
|
Will Patient Plan for Work Absence
Not applicable
|
43 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Day 7 after enrollmentDid the time to receive test results affect you and prevent you from doing activities you normally would do?
Outcome measures
| Measure |
BioFire® Respiratory Panel 2.1-EZ
n=156 Participants
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
BioFire® Respiratory Panel 2.1-EZ: 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.
|
Standard of Care
n=124 Participants
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.
|
|---|---|---|
|
Did the Time to Receive Test Results Affect You and Prevent You From Doing Activities You Normally Would do?
Yes
|
26 participants
|
38 participants
|
|
Did the Time to Receive Test Results Affect You and Prevent You From Doing Activities You Normally Would do?
No
|
130 participants
|
86 participants
|
SECONDARY outcome
Timeframe: Day 7 after enrollmentOutcome measures
| Measure |
BioFire® Respiratory Panel 2.1-EZ
n=156 Participants
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
BioFire® Respiratory Panel 2.1-EZ: 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.
|
Standard of Care
n=122 Participants
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.
|
|---|---|---|
|
I am Satisfied With the Time it Took to Receive the Test Results.
Strongly agree/Agree
|
145 Participants
|
73 Participants
|
|
I am Satisfied With the Time it Took to Receive the Test Results.
Neither agree or disagree
|
7 Participants
|
16 Participants
|
|
I am Satisfied With the Time it Took to Receive the Test Results.
Strongly disagree/Disagree
|
4 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Day of EnrollmentPractitioner-Centered Results
Outcome measures
| Measure |
BioFire® Respiratory Panel 2.1-EZ
n=155 Participants
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
BioFire® Respiratory Panel 2.1-EZ: 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.
|
Standard of Care
n=104 Participants
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.
|
|---|---|---|
|
Were Antibiotics Prescribed as Part of the IPC Visit for Respiratory Illness?
Yes
|
52 Participants
|
27 Participants
|
|
Were Antibiotics Prescribed as Part of the IPC Visit for Respiratory Illness?
No
|
103 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: Day of EnrollmentHow confident are you that you know what is causing your patient's illness?
Outcome measures
| Measure |
BioFire® Respiratory Panel 2.1-EZ
n=155 Participants
EXP group will receive the BioFire RP2.1-EZ panel, designed to test for a variety of bacterial and/or viral causes for illness
BioFire® Respiratory Panel 2.1-EZ: 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.
|
Standard of Care
n=104 Participants
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.
|
|---|---|---|
|
Confidence in Patient's Cause of Illness
Less confident
|
10 Participants
|
15 Participants
|
|
Confidence in Patient's Cause of Illness
No effect
|
20 Participants
|
41 Participants
|
|
Confidence in Patient's Cause of Illness
More satisfied
|
125 Participants
|
48 Participants
|
Adverse Events
BioFire® Respiratory Panel 2.1-EZ
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
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