NCT04048369

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
431

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 7, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

July 26, 2019

Last Update Submit

August 6, 2019

Conditions

Influenza

Keywords

influenzapoint-of-care testingpolymerase chain reactionemergency medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Prescription of antibiotics initiated at the adults emergency department

    within 72 hours after taking care of the patient

  • Duration of the prescription of antibiotics initiated at the adults emergency department

    within 72 hours after taking care of the patient

  • Posology of antibiotics initiated at the adults emergency department

    within 72 hours after taking care of the patient

  • Costs of antibiotics initiated at the adults emergency department

    within 72 hours after taking care of the patient

  • Prescription of antiviral initiated in adults emergency department

    within 72 hours after taking care of the patient

  • +8 more secondary outcomes

Study Arms (2)

Point-of-care testing arm

EXPERIMENTAL

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

Core Lab testing arm

ACTIVE COMPARATOR

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

Interventions

Rapid diagnosis of influenza in the emergency medical serviceDIAGNOSTIC_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 armPoint-of-care testing arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

Related Publications (7)

  • 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.

    PMID: 26788921BACKGROUND

  • 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.

    PMID: 29137903BACKGROUND

  • 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.

    PMID: 28392237BACKGROUND

  • 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.

    PMID: 30207514BACKGROUND

  • 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.

    PMID: 30185508BACKGROUND

  • 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.

    PMID: 30026005BACKGROUND

  • 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.

    PMID: 29769281BACKGROUND

Related Links

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Cécile Henquell, PU-PH

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2019

First Posted

August 7, 2019

Study Start

January 17, 2019

Primary Completion

March 14, 2019

Study Completion

December 31, 2019

Last Updated

August 7, 2019

Record last verified: 2019-06

Locations

FR(1)