Trial Outcomes & Findings for Evaluation of the Roche Liat Flu/RSV Assay for Management of Influenza in the Emergency Department (NCT NCT02899065)
NCT ID: NCT02899065
Last Updated: 2023-10-17
Results Overview
The determination of whether use of the Roche Cobas/Liat Flu/RSV Assay as part of a stewardship intervention reduces antibiotic treatment for pediatric ED patients with suspected influenza. Proper adherence to treatment guidelines after results should reduce physician prescription of antibiotic for non-responsive conditions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
During ED stay, up to 48 hours
Results posted on
2023-10-17
Participant Flow
Participants were recruited after presentation to the Emergency Department between March 2018 and April 2022 at the University of California Davis Medical Center.
During the enrollment period, 1259 ED patients were assessed for inclusion and 200 were randomized into the research study.
Participant milestones
| Measure |
Intervention Arm
Participants enrolled to the intervention arm received a procalcitonin lab test along with the standard of care Roche Cobas Liat Flu/RSV lab testing. The intervention also included pharmacist-led education and stewardship to the treating clinician about interpreting the Roche Cobas Liat Flu/RSV and procalcitonin test results, recommendations for antiviral-treatment for high-risk patients, and information about infection control precautions for patients being hospitalized with a positive RSV or influenza test.
|
Standard of Care
This arm consisted of the delivery of Emergency Department usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results were delivered via standard of care reporting.
|
|---|---|---|
|
Randomization to 7 Day Follow Up Contact
STARTED
|
100
|
100
|
|
Randomization to 7 Day Follow Up Contact
COMPLETED
|
99
|
95
|
|
Randomization to 7 Day Follow Up Contact
NOT COMPLETED
|
1
|
5
|
|
Day 7 to 4 Week Follow Up Contact
STARTED
|
99
|
95
|
|
Day 7 to 4 Week Follow Up Contact
COMPLETED
|
75
|
79
|
|
Day 7 to 4 Week Follow Up Contact
NOT COMPLETED
|
24
|
16
|
Reasons for withdrawal
| Measure |
Intervention Arm
Participants enrolled to the intervention arm received a procalcitonin lab test along with the standard of care Roche Cobas Liat Flu/RSV lab testing. The intervention also included pharmacist-led education and stewardship to the treating clinician about interpreting the Roche Cobas Liat Flu/RSV and procalcitonin test results, recommendations for antiviral-treatment for high-risk patients, and information about infection control precautions for patients being hospitalized with a positive RSV or influenza test.
|
Standard of Care
This arm consisted of the delivery of Emergency Department usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results were delivered via standard of care reporting.
|
|---|---|---|
|
Randomization to 7 Day Follow Up Contact
Withdrawal by Subject
|
1
|
5
|
|
Day 7 to 4 Week Follow Up Contact
Withdrawal by Subject
|
3
|
0
|
|
Day 7 to 4 Week Follow Up Contact
Lost to Follow-up
|
21
|
16
|
Baseline Characteristics
Not all patients who present to the ED have their height measured; therefore, a portion of the study population do not have a recorded height.
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=100 Participants
Participants enrolled to the intervention arm received a procalcitonin lab test along with the standard of care Roche Cobas Liat Flu/RSV lab testing. The intervention also included pharmacist-led education and stewardship to the treating clinician about interpreting the Roche Cobas Liat Flu/RSV and procalcitonin test results, recommendations for antiviral-treatment for high-risk patients, and information about infection control precautions for patients being hospitalized with a positive RSV or influenza test.
|
Standard of Care
n=100 Participants
This arm consisted of the delivery of Emergency Department usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results were delivered via standard of care reporting.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
149 months
STANDARD_DEVIATION 157 • n=100 Participants
|
124 months
STANDARD_DEVIATION 140 • n=100 Participants
|
136 months
STANDARD_DEVIATION 149 • n=200 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=100 Participants
|
47 Participants
n=100 Participants
|
91 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=100 Participants
|
53 Participants
n=100 Participants
|
109 Participants
n=200 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
49 Participants
n=100 Participants
|
46 Participants
n=100 Participants
|
95 Participants
n=200 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=100 Participants
|
100 participants
n=100 Participants
|
200 participants
n=200 Participants
|
|
Education - n = Some college
|
16 Participants
n=100 Participants
|
11 Participants
n=100 Participants
|
27 Participants
n=200 Participants
|
|
Height
|
50.5 inches
STANDARD_DEVIATION 16.5 • n=80 Participants • Not all patients who present to the ED have their height measured; therefore, a portion of the study population do not have a recorded height.
|
50.8 inches
STANDARD_DEVIATION 14.9 • n=77 Participants • Not all patients who present to the ED have their height measured; therefore, a portion of the study population do not have a recorded height.
|
50.7 inches
STANDARD_DEVIATION 15.7 • n=157 Participants • Not all patients who present to the ED have their height measured; therefore, a portion of the study population do not have a recorded height.
|
|
Weight
|
40.0 kilograms
STANDARD_DEVIATION 33.7 • n=99 Participants • Not all patients who present to the ED are weighed; therefore, a small portion of the study population do not have a recorded weight.
|
38.7 kilograms
STANDARD_DEVIATION 34.6 • n=97 Participants • Not all patients who present to the ED are weighed; therefore, a small portion of the study population do not have a recorded weight.
|
39.3 kilograms
STANDARD_DEVIATION 34.1 • n=196 Participants • Not all patients who present to the ED are weighed; therefore, a small portion of the study population do not have a recorded weight.
|
|
Temperature
|
37.7 celsius
STANDARD_DEVIATION 1.1 • n=100 Participants • One participant did not have a recorded temperature.
|
37.6 celsius
STANDARD_DEVIATION 1.0 • n=99 Participants • One participant did not have a recorded temperature.
|
37.6 celsius
STANDARD_DEVIATION 1.0 • n=199 Participants • One participant did not have a recorded temperature.
|
|
Influenza A positive
|
13 Participants
n=100 Participants
|
11 Participants
n=100 Participants
|
24 Participants
n=200 Participants
|
|
Influenza B positive
|
8 Participants
n=100 Participants
|
5 Participants
n=100 Participants
|
13 Participants
n=200 Participants
|
|
Respiratory syncytial virus - RSV positive
|
7 Participants
n=100 Participants
|
7 Participants
n=100 Participants
|
14 Participants
n=200 Participants
|
PRIMARY outcome
Timeframe: During ED stay, up to 48 hoursThe determination of whether use of the Roche Cobas/Liat Flu/RSV Assay as part of a stewardship intervention reduces antibiotic treatment for pediatric ED patients with suspected influenza. Proper adherence to treatment guidelines after results should reduce physician prescription of antibiotic for non-responsive conditions.
Outcome measures
| Measure |
Intervention Arm
n=100 Participants
Participants enrolled to the intervention arm received a procalcitonin lab test along with the standard of care Roche Cobas Liat Flu/RSV lab testing. The intervention also included pharmacist-led education and stewardship to the treating clinician about interpreting the Roche Cobas Liat Flu/RSV and procalcitonin test results, recommendations for antiviral-treatment for high-risk patients, and information about infection control precautions for patients being hospitalized with a positive RSV or influenza test.
|
Standard of Care
n=100 Participants
This arm consisted of the delivery of Emergency Department usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results were delivered via standard of care reporting.
|
|---|---|---|
|
Number of Participants Prescribed Antibiotics
|
39 Participants
|
32 Participants
|
PRIMARY outcome
Timeframe: During ED stay, up to 48 hoursThe determination of whether use of the Roche Cobas Liat Flu/RSV Assay as part of a formal stewardship intervention optimizes antiviral treatment of pediatric ED patients with influenza at risk of complications.
Outcome measures
| Measure |
Intervention Arm
n=100 Participants
Participants enrolled to the intervention arm received a procalcitonin lab test along with the standard of care Roche Cobas Liat Flu/RSV lab testing. The intervention also included pharmacist-led education and stewardship to the treating clinician about interpreting the Roche Cobas Liat Flu/RSV and procalcitonin test results, recommendations for antiviral-treatment for high-risk patients, and information about infection control precautions for patients being hospitalized with a positive RSV or influenza test.
|
Standard of Care
n=100 Participants
This arm consisted of the delivery of Emergency Department usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results were delivered via standard of care reporting.
|
|---|---|---|
|
Number of Participants Prescribed Antiviral Therapy
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Number of participants who tested positive during their initial ED visit
Emergency Department return visits within 30 days for patients diagnosed with influenza and RSV
Outcome measures
| Measure |
Intervention Arm
n=28 Participants
Participants enrolled to the intervention arm received a procalcitonin lab test along with the standard of care Roche Cobas Liat Flu/RSV lab testing. The intervention also included pharmacist-led education and stewardship to the treating clinician about interpreting the Roche Cobas Liat Flu/RSV and procalcitonin test results, recommendations for antiviral-treatment for high-risk patients, and information about infection control precautions for patients being hospitalized with a positive RSV or influenza test.
|
Standard of Care
n=23 Participants
This arm consisted of the delivery of Emergency Department usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results were delivered via standard of care reporting.
|
|---|---|---|
|
Emergency Department Recidivism
|
19 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 7 days and again at week 4Population: The total participants randomized in the study was 200 with an equal number in both arms (100). Of the 100 participants randomized to each arm, only 87 were able to be contacted in the intervention arm and 82 participants in the standard of care arm at Day 7. At week 4, 76 participants were able to be contacted in the intervention arm and 77 were contacted in the standard of care arm. The remaining participants were either lost to follow up or withdrew consent for participation in the study.
Time to resolution of symptoms such as fever, cough or sore throat
Outcome measures
| Measure |
Intervention Arm
n=87 Participants
Participants enrolled to the intervention arm received a procalcitonin lab test along with the standard of care Roche Cobas Liat Flu/RSV lab testing. The intervention also included pharmacist-led education and stewardship to the treating clinician about interpreting the Roche Cobas Liat Flu/RSV and procalcitonin test results, recommendations for antiviral-treatment for high-risk patients, and information about infection control precautions for patients being hospitalized with a positive RSV or influenza test.
|
Standard of Care
n=82 Participants
This arm consisted of the delivery of Emergency Department usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results were delivered via standard of care reporting.
|
|---|---|---|
|
Symptom Resolution
Symptoms Resolved by Day 7
|
66 Participants
|
52 Participants
|
|
Symptom Resolution
Symptoms resolved by Week 4
|
62 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: 7 days and again at week 4Population: The total participants randomized in the study was 200 with an equal number in both arms (100). Of the 100 participants randomized to each arm, only 87 were able to be contacted in the intervention arm and 82 participants in the standard of care arm at Day 7. At week 4, 76 participants were able to be contacted in the intervention arm and 77 were contacted in the standard of care arm. The remaining participants were either lost to follow up or withdrew consent for participation in the study.
Number of days of school and/or work missed due to illness
Outcome measures
| Measure |
Intervention Arm
n=87 Participants
Participants enrolled to the intervention arm received a procalcitonin lab test along with the standard of care Roche Cobas Liat Flu/RSV lab testing. The intervention also included pharmacist-led education and stewardship to the treating clinician about interpreting the Roche Cobas Liat Flu/RSV and procalcitonin test results, recommendations for antiviral-treatment for high-risk patients, and information about infection control precautions for patients being hospitalized with a positive RSV or influenza test.
|
Standard of Care
n=82 Participants
This arm consisted of the delivery of Emergency Department usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results were delivered via standard of care reporting.
|
|---|---|---|
|
Lost Days of School/Work
School days missed at day 7
|
2.6 Days
Standard Deviation 3.0
|
2.6 Days
Standard Deviation 3.1
|
|
Lost Days of School/Work
Work days missed at day 7
|
2.5 Days
Standard Deviation 2.7
|
3.1 Days
Standard Deviation 3.1
|
|
Lost Days of School/Work
School days missed at week 4
|
1.8 Days
Standard Deviation 3.7
|
1.4 Days
Standard Deviation 4.1
|
|
Lost Days of School/Work
Work days missed at week 4
|
0.9 Days
Standard Deviation 1.7
|
1.2 Days
Standard Deviation 3.6
|
Adverse Events
Intervention Arm
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
Larissa May, MD, MSHS, MSPH, Director of Emergency Medicine Innovation and External Partnerships
UC Davis Medical Center
Phone: 916-734-1593
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place