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

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

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.

Study Overview

• Status: Unknown
• Conditions: Influenza
• Intervention / Treatment: Diagnostic test: Rapid diagnosis of influenza in the emergency medical service

Detailed Description

• 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.

• Study Type: Interventional
• Enrollment (Actual): 431
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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).
Active Comparator: 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)	Diagnostic test: 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Cécile Henquell, PU-PH, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• Soto M, Sampietro-Colom L, Vilella A, Pantoja E, Asenjo M, Arjona R, Hurtado JC, Trilla A, Alvarez-Martinez MJ, Mira A, Vila J, Marcos MA. Economic Impact of a New Rapid PCR Assay for Detecting Influenza Virus in an Emergency Department and Hospitalized Patients. PLoS One. 2016 Jan 20;11(1):e0146620. doi: 10.1371/journal.pone.0146620. eCollection 2016.
• Trabattoni E, Le V, Pilmis B, Pean de Ponfilly G, Caisso C, Couzigou C, Vidal B, Mizrahi A, Ganansia O, Le Monnier A, Lina B, Nguyen Van JC. Implementation of Alere i Influenza A & B point of care test for the diagnosis of influenza in an ED. Am J Emerg Med. 2018 Jun;36(6):916-921. doi: 10.1016/j.ajem.2017.10.046. Epub 2017 Oct 18.
• Brendish NJ, Malachira AK, Armstrong L, Houghton R, Aitken S, Nyimbili E, Ewings S, Lillie PJ, Clark TW. Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial. Lancet Respir Med. 2017 May;5(5):401-411. doi: 10.1016/S2213-2600(17)30120-0. Epub 2017 Apr 6.
• Ho YII, Wong AH, Lai RWM. Comparison of the Cepheid Xpert Xpress Flu/RSV Assay to in-house Flu/RSV triplex real-time RT-PCR for rapid molecular detection of Influenza A, Influenza B and Respiratory Syncytial Virus in respiratory specimens. J Med Microbiol. 2018 Nov;67(11):1576-1580. doi: 10.1099/jmm.0.000841. Epub 2018 Sep 12.
• Banerjee D, Kanwar N, Hassan F, Essmyer C, Selvarangan R. Comparison of Six Sample-to-Answer Influenza A/B and Respiratory Syncytial Virus Nucleic Acid Amplification Assays Using Respiratory Specimens from Children. J Clin Microbiol. 2018 Oct 25;56(11):e00930-18. doi: 10.1128/JCM.00930-18. Print 2018 Nov.
• Bennett S, MacLean A, Gunson R. Verification of Cepheid Xpert Xpress Flu/RSV assay for use with gargle samples, sputa and endotracheal secretions. J Hosp Infect. 2019 Jan;101(1):114-115. doi: 10.1016/j.jhin.2018.07.016. Epub 2018 Jul 17. No abstract available.
• Popowitch EB, Miller MB. Comparison of the Xpert Flu/RSV XC and Xpress Flu/RSV Assays. J Clin Microbiol. 2018 Jul 26;56(8):e00278-18. doi: 10.1128/JCM.00278-18. Print 2018 Aug.

Helpful Links

• Procédure actualisée de prise en charge globale d'un patient suspect de grippe saisonnière
• Nucleic Acid Detection Based Tests
• Information on Rapid Molecular Assays, RT-PCR, and other Molecular Assays for Diagnosis of Influenza Virus Infection

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Actual): March 14, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: influenza; emergency medicine; polymerase chain reaction; point-of-care testing
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Orthomyxoviridae Infections; Emergencies; Influenza, Human
• Other Study ID Numbers: RBHP 2018 HENQUELL; 2018-A02478-47 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No