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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

431 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2019-12-31

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.

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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.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Point-of-care testing arm

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.

Group Type EXPERIMENTAL

Rapid diagnosis of influenza in the emergency medical service

Intervention Type DIAGNOSTIC_TEST

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).

Core Lab testing arm

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)

Group Type ACTIVE_COMPARATOR

Rapid diagnosis of influenza in the emergency medical service

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

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Rapid diagnosis of influenza in the emergency medical service

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).

Intervention Type DIAGNOSTIC_TEST

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No