Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-31 @ 9:16 PM
Study NCT ID:
NCT04048369
Status:
UNKNOWN
Last Update Posted:
2019-08-07
First Post:
2019-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Influenza/RSV PCR Point-of-care Testing in the Emergency Medical Service.
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Impact Study of a Rapid Diagnosis of Influenza in the Emergency Medical Service During the 2018-2019 Epidemic Season
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-A02478-47 | OTHER | ANSM | View |