Impact of Influenza/RSV PCR Point-of-care Testing in the Emergency Medical Service.

Study Overview
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Brief Summary
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The purpose of the study is to compare Emergency Department patients who undergo influenza and RSV PCR testing using an FDA-approved point-of-care device (Cepheid Xpert® Xpress Flu/RSV) located in the ED, to patients who undergo influenza and RSV PCR testing at the core laboratory. The principal purpose is to determine if the time spent in the ED is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing.

Detailed Description
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This study will be conducted during the influenza's epidemic season. The start and the end of this study will be determined using national epidemic bases (national reference center for inluenza in Lyon). Collection of consent of eligible patients after medical information by a senior emergency physician Sampling = nasopharyngeal swabbing for all patients using usual testing or point-of-care testing first arm : performing the test at the adult emergency department 24h/24 second arm : sending the test to the virology laboratory and realization during working hours Collection of clinical data : a specific standardized questionnaire is used, as soon as the patient is included and until he leaves the emergency medical service, to collect clinical data and the time taken to take care of the patient In order to reduce the bias of this study, it has been established : After verification of the eligibility criteria and obtaining the written consent of the patient, a randomization procedure will be initiated for the patient. Randomization will be centralized at the DRCI of Clermont-Ferrand University Hospital. Patients will be randomly assigned to one of the study groups by means of individual block randomization. A document describing the randomization procedure will be kept confidentially in the DRCI of Clermont-Ferrand University Hospital; - The collection of data will be prospective. A listing of patients opposing to the study's participation to verify that their characteristics are homogeneous to the general population The choice of the Genexpert® automaton used in the point of care testing arm whose principle of operation requires a minimum of manipulations (<2 minutes) and does not generate inter-operator variability Statistical analyzes will be performed with the Stata software (version 13, StataCorp, College Station). All statistical tests will be carried out at the risk of error of the first species α of 5%. Part of the analysis of the secondary endpoints should be primarily exploratory in nature. As discussed by Feise in 2002 (Feise RJ, Do 2: 8), the adjustment of the risk of error of 1st species will not be proposed systematically, but case by case in view of clinical considerations and not just statistical ones. Continuous variables will be presented as mean and standard deviation, subject to the normality of their distribution (Shapiro-Wilk test if necessary). In case of non-normality, they will be presented as median, quartiles, and extreme values. The qualitative variables will be expressed in numbers and percentages associated. Graphic representations will be associated with these analyzes as much as possible.

Official Title
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Impact Study of a Rapid Diagnosis of Influenza in the Emergency Medical Service During the 2018-2019 Epidemic Season

Conditions
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Influenza

Intervention / Treatment
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* Diagnostic Test: Rapid diagnosis of influenza in the emergency medical service


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : 18 years old and older coming in the emergency medical service during the influenza epidemic period with influenza symptoms whose support requires virologic confirmation people having given their consent Exclusion criteria : pregnant or breast feeding women patient unable to give consent tutorship or curatorship or under the protection of justice patient non registered in the social security system

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Point-of-care testing arm<br>for patients randomized to the Point-of-care testing arm, nurse will perform influenza and RSV testing using an FDA-approved point-of-care device (Cepheid Xpert® Xpress Flu/RSV) in the ED, 24/24, 7/7. | Diagnostic Test: Rapid diagnosis of influenza in the emergency medical service<br>* Comparison at the University Hospital of Clermont-Ferrand of a test performed in the Adult Emergencies Department by the nursing staff (point-of-care testing) to a test carried out in the core laboratory (classical testing).<br>|
| Active Comparator: Core Lab testing arm<br>for patients randomized to the Core lab testing arm, influenza/RSV PCR will be performed in the core virology laboratory using Simplexa Flu A/B and RSV direct (r) assay (Diasorin), during working hours (8 am-6pm Monday to Friday, 8 am-5pm the Saturday) | Diagnostic Test: Rapid diagnosis of influenza in the emergency medical service<br>* Comparison at the University Hospital of Clermont-Ferrand of a test performed in the Adult Emergencies Department by the nursing staff (point-of-care testing) to a test carried out in the core laboratory (classical testing).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of care in the adult emergency department | Emergency care time, calculated from the time of first medical-care contact to the time of release of the adults emergency department. This time will be calculated from the data collected on the standardized questionnaire | through study completion, an average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription of antibiotics initiated at the adults emergency department | nature of antibiotics | within 72 hours after taking care of the patient | 
| Duration of the prescription of antibiotics initiated at the adults emergency department | duration of treatment (day) | within 72 hours after taking care of the patient | 
| Posology of antibiotics initiated at the adults emergency department | posology (mg) | within 72 hours after taking care of the patient | 
| Costs of antibiotics initiated at the adults emergency department | associated costs (euros) | within 72 hours after taking care of the patient | 
| Prescription of antiviral initiated in adults emergency department | nature of antiviral prescription | within 72 hours after taking care of the patient | 
| Duration of the specific antiviral prescription initiated in adults emergency department | duration of treatment (day) | within 72 hours after taking care of the patient | 
| Costs of specific antiviral prescription initiated in adults emergency department | associated costs (euros) | within 72 hours after taking care of the patient | 
| Type of prescription of imaging tests at the adults emergency department | type of examinations related to the patient respiratory pathology | within 72 hours after taking care of the patient | 
| Number of prescription of imaging tests at the adults emergency department | Number of examinations related to the patient respiratory pathology | within 72 hours after taking care of the patient | 
| Costs of the prescription of imaging tests at the adults emergency department | Costs of examinations related to the patient respiratory pathology (euros) | within 72 hours after taking care of the patient | 
| Type of prescription of biology examinations | type of laboratory examinations related to respiratory pathology | within 72 hours after taking care of the patient | 
| Number of prescription of biology examinations | Number of laboratory examinations related to respiratory pathology | within 72 hours after taking care of the patient | 
| Costs of prescription of biology examinations | Costs of laboratory examinations related to respiratory pathology (euros) | within 72 hours after taking care of the patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, point-of-care testing, polymerase chain reaction, emergency medicine