InfluenzaNCT04048369
Impact of Influenza/RSV PCR Point-of-care Testing in the Emergency Medical Service.
A study testing Rapid diagnosis of influenza in the emergency medical service in people with Influenza, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Rapid diagnosis of influenza in the emergency medical service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Influenza
- Being tested
- Rapid diagnosis of influenza in the emergency medical service
- Keywords
- influenza, point-of-care testing, polymerase chain reaction, emergency medicine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Diagnostic Test: Rapid diagnosis of influenza in the emergency medical service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 week
Secondary outcomes (13)
Prescription of antibiotics initiated at the adults emergency department
nature of antibiotics
Measured: 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)
Measured: within 72 hours after taking care of the patient
Posology of antibiotics initiated at the adults emergency department
posology (mg)
Measured: within 72 hours after taking care of the patient
Costs of antibiotics initiated at the adults emergency department
associated costs (euros)
Measured: within 72 hours after taking care of the patient
Prescription of antiviral initiated in adults emergency department
nature of antiviral prescription
Measured: within 72 hours after taking care of the patient
Duration of the specific antiviral prescription initiated in adults emergency department
duration of treatment (day)
Measured: within 72 hours after taking care of the patient
Costs of specific antiviral prescription initiated in adults emergency department
associated costs (euros)
Measured: 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
Measured: 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
Measured: 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)
Measured: within 72 hours after taking care of the patient
Type of prescription of biology examinations
type of laboratory examinations related to respiratory pathology
Measured: within 72 hours after taking care of the patient
Number of prescription of biology examinations
Number of laboratory examinations related to respiratory pathology
Measured: within 72 hours after taking care of the patient
Costs of prescription of biology examinations
Costs of laboratory examinations related to respiratory pathology (euros)
Measured: within 72 hours after taking care of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start17 Jan 2019
- Primary completion14 Mar 2019
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Henquell, PU-PH, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048369
- Sponsor's protocol ID
- RBHP 2018 HENQUELL
- Other IDs
- 2018-A02478-47
- Status last verified
- Jun 2019
- First submitted
- 26 Jul 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26788921Trabattoni 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.
PubMed 29137903Brendish 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.
PubMed 28392237Ho 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.
PubMed 30207514Banerjee 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.
PubMed 30185508Bennett 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.
PubMed 30026005Popowitch 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.
PubMed 29769281
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Study of a Rapid Diagnosis of Influenza in the Emergency Medical Service During the 2018-2019 Epidemic Season
- ClinicalTrials.gov ID
- NCT04048369
- Acronym / sponsor ID
- RBHP 2018 HENQUELL
- Conditions
- Influenza
- Keywords
- influenza, point-of-care testing, polymerase chain reaction, emergency medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 431 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point-of-care testing arm | Experimental | Diagnostic Test: Rapid diagnosis of influenza in the emergency medical servicefor 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. |
| Core Lab testing arm | Active comparator | Diagnostic Test: Rapid diagnosis of influenza in the emergency medical servicefor 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old and older
- coming in the emergency medical service
- during the influenza epidemic period
- with influenza symptoms
- whose support requires virologic confirmation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid diagnosis of influenza in the emergency medical serviceComparison 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). | Diagnostic test | Core Lab testing arm, Point-of-care testing arm |
Primary outcome
Time of care in the adult emergency department
Time frame: through study completion, an average of 1 week
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
13 secondary outcomes
Prescription of antibiotics initiated at the adults emergency department
Time frame: within 72 hours after taking care of the patient
Duration of the prescription of antibiotics initiated at the adults emergency department
Time frame: within 72 hours after taking care of the patient
Posology of antibiotics initiated at the adults emergency department
Time frame: within 72 hours after taking care of the patient
Costs of antibiotics initiated at the adults emergency department
Time frame: within 72 hours after taking care of the patient
Prescription of antiviral initiated in adults emergency department
Time frame: within 72 hours after taking care of the patient
Duration of the specific antiviral prescription initiated in adults emergency department
Time frame: within 72 hours after taking care of the patient
Costs of specific antiviral prescription initiated in adults emergency department
Time frame: within 72 hours after taking care of the patient
Type of prescription of imaging tests at the adults emergency department
Time frame: within 72 hours after taking care of the patient
Number of prescription of imaging tests at the adults emergency department
Time frame: within 72 hours after taking care of the patient
Costs of the prescription of imaging tests at the adults emergency department
Time frame: within 72 hours after taking care of the patient
Type of prescription of biology examinations
Time frame: within 72 hours after taking care of the patient
Number of prescription of biology examinations
Time frame: within 72 hours after taking care of the patient
Costs of prescription of biology examinations
Time frame: within 72 hours after taking care of the patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 26788921Soto 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.
- Background: PubMed 29137903Trabattoni 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.
- Background: PubMed 28392237Brendish 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.
- Background: PubMed 30207514Ho 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.
- Background: PubMed 30185508Banerjee 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.
- Background: PubMed 30026005Bennett 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.
- Background: PubMed 29769281Popowitch 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.
- Procédure actualisée de prise en charge globale d'un patient suspect de grippe saisonnièreLink provided by the sponsor.
- Nucleic Acid Detection Based TestsLink provided by the sponsor.
- Information on Rapid Molecular Assays, RT-PCR, and other Molecular Assays for Diagnosis of Influenza Virus InfectionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Henquell, PU-PH principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid diagnosis of influenza in the emergency medical service in people with Influenza, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of care in the adult emergency department (time frame: through study completion, an average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048369, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.