SARS-CoV InfectionDEPIST-COVIDNCT04756609
Systematic Offer of Nurse-Driven Screening for COVID-19 in Emergency Departments in the Paris Metropolitan Area, DEPIST-COVID
A study testing Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practice and Usual emergency department practice with physician-directed diagnostic testing in people with SARS-CoV Infection and Nurse's Role, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
European countries faced another wave of the SARS-CoV2 pandemic, which has led to a second lockdown in France in November 2020 in order to avoid overwhelming health services. To prevent or reduce another wave, the strategy calls for vaccination, maintaining barrier measures and testing and isolating infected persons… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection, Nurse's Role
- What is being tested?
- Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practice and Usual emergency department practice with physician-directed diagnostic testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138,352 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2021to 15 Jun 2021
- 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
- All consulting adults visiting a participating ED
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Benefit of a Systematic Offer of Nurse-Driven SARS-Cov2 Screening by Rapid Testing in Emergency Departments in the Paris Metropolitan Area
European countries faced another wave of the SARS-CoV2 pandemic, which has led to a second lockdown in France in November 2020 in order to avoid overwhelming health services. To prevent or reduce another wave, the strategy calls for vaccination, maintaining barrier measures and testing and isolating infected persons in order to break the cycles of infection. The latter objective is made difficult by the existence of asymptomatic carriers or symptomatic carriers that have very few symptoms and that aren't tested. Identification of these carriers in the general population is usually based on a search for close contact persons from those who were tested positive or from identified clusters.
Experiments of mass testing are being carried out or were carried out, for example in Liverpool or Slovakia but, in order for them to be effective, they must be repeated, which limits feasibility. Another strategy of wide screening in the general population to identify asymptomatic persons is to offer a systematic screening during medical consultations and particularly in the emergency departments (ED). This strategy grants access to the entire population attending health facilities, including persons with lower income. This strategy can be conducted continuously in order to: 1) contribute to controlling the epidemic by identifying and isolating asymptomatic persons and their close contacts; 2) provide an observatory on the evolution of viral circulation in the general population.
Read more
To the best the knowledge, this strategy has not been evaluated and will be tested it in 18 emergency departments in the Paris Metropolitan area, one of the most SARS-CoV2 affected regions.
The aim is to evaluate the benefit of a systematic offer of SARS-Cov2 screening by rapid testing (molecular multiplex PCR/ RT-LAMP) to identify infected persons, associated with the usual practice of the EDs (intervention strategy) compared to a period based on usual practice of the EDs (control strategy)
The strategies will be compared during two periods following a cluster-randomized two-period crossover design.
During intervention periods, nurses will suggest performing a SARS-CoV2 test to patients using a PCR multiplex for symptomatic patients and a RT-LAMP for asymptomatic patients.
Read the detailed description
European countries faced another wave of the SARS-CoV2 pandemic, which has led to a lockdown in France in November 2020 in order to avoid overwhelming health services. To prevent or reduce another wave, the strategy calls for vaccination, maintaining barrier measures and testing and isolating infected persons in order to break the cycles of infection. The latter objective is made difficult by the existence of asymptomatic carriers or symptomatic carriers that have very few symptoms and that aren't tested. Identification of these carriers in the general population is usually based on a search for close contact persons from those who were tested positive or from identified clusters.
Experiments of mass testing are being carried out or were carried out, for example in Liverpool or Slovakia but, in order for them to be effective, they must be repeated, which limits feasibility. Another strategy of wide screening in the general population to identify asymptomatic persons is to offer a systematic screening during medical consultations and particularly in the emergency departments (ED). This strategy grants access to the entire population attending health facilities, including persons with lower income. This strategy can be conducted continuously in order to: 1) contribute to controlling the epidemic by identifying and isolating asymptomatic persons and their close contacts; 2) provide an observatory on the evolution of viral circulation in the general population.
To the best of the knowledge, this strategy has not been evaluated and will be tested it in 18 emergency departments in the Paris Metropolitan area (Ile-de-France), one of the most SARS-CoV2 affected regions.
The primary objective is to evaluate the benefit of a systematic offer of nurse-driven SARS-Cov2 screening by rapid testing (molecular multiplex PCR/ RT-LAMP) to identify infected persons, associated with the usual practice of the EDs (intervention strategy) compared to a period based on usual practice of the EDs (control strategy).
The primary outcome is the proportion of patients tested positive for SARS-CoV2 amongst the flow of consulting adults.
The secondary outcomes are to:
- compare the proportion of patients tested positive for SARS-CoV2 amongst asymptomatic patients tested in the Paris Metropolitan area at the same period (the comparison will also be done amongst the geographical area of each ED, amongst symptomatic patients tested and also amongst the entire tested population)
- evaluate the feasibility of the screening strategy
- describe the patients tested for SARS-Cov2 in both periods :
- proportion of positive tests
- proportion of asymptomatic patients amongst tested patients and amongst SARS-Cov2 positive patients
- For the symptomatic patients tested positive : symptomology
- Patient exposure factors with the DEPIST-COVID questionnaire and according to SARS-Cov2 test result.
- describe socio-demographic and behavioral factors and habits associated with SARS-Cov2 infection in patients tested in one of the following schemes: DEPIST-COVID, ComCor (Pasteur Institute) and COVISAN.
- estimate the incidence of new SARS-Cov2 infections in the Paris Metropolitan area: proportion of positive patients and their profiles. To estimate the under-detection of cases in the region, and compare with results from the model experiment.
- estimate the number of close contact persons who have been tested for SARS-Cov2, who have been tested positive and who have been isolated over both periods.
Methods The strategies will be compared during two periods in 18 EDS of Paris metropolitan area following a cluster-randomized two-period crossover design. Each period will last 1 month. Patients will participate to a follow-up call (within 15 days ±10). The periods will be separated by an expected period of washout of a minimum of 1 day .
During intervention periods, nurses will suggest performing a SARS-CoV2 test to patients. According to the answers to a self-administered questionnaire, a PCR multiplex will be performed for symptomatic patients and a RT-LAMP for asymptomatic patients.
- Conditions
- SARS-CoV Infection, Nurse's Role
- Being tested
- Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practice, Usual emergency department practice with physician-directed diagnostic testing
- Keywords
- SARS-CoV-2, Mass screening, Emergency service, hospital Nurses, Prevention and control
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practiceProcedure or surgery
I- A SARS-CoV2 self-administered questionnaire about SARS-CoV2 symptoms, possibilities of close contacts, risk exposure situations and socio-demographic characteristics will be offered to patients included who are capable of filling it out.
- The patient will fill out the questionnaire and hand it in to the nurse caring for him/her.
- The nurse, regardless of the answers to the questionnaire, will offer the SARS-CoV2 screening.
- A nasopharyngeal swab for SARS-CoV2 will be carried out.
- A patient will be considered as symptomatic if he/she presents one or more symptoms listed in the questionnaire.
- For symptomatic patients, a SARS-CoV2 for multiplex PCR will be carried out. This analysis takes 75 minutes.
- For asymptomatic patients, a RT-LAMP test will be carried out. This analysis takes 5 to 15 minutes.
Usual emergency department practice with physician-directed diagnostic testingOther
The physician offers a SARS-CoV2 test according to current recommendations. The tests are prescribed as a means of diagnosis for patients presenting symptoms suggestive of Covid-19 or as a means of diagnosis for patients requiring hospitalisation for another cause, before their transfer to hospital. Patients will be cared for according to usual procedures of each hospital. Patients tested positive will be asked to fill out the DEPIST-COVID questionnaire. Patients who had not completed it will be contacted by phone to answer the questions over the phone.
| Study group | Role | What they receive |
|---|---|---|
| Systematic offer of nurse-driven SARS-CoV-2 screening + usual practice | Experimental | Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practice Receives: Procedure: Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practice |
| Control group: Usual emergency department practice | Active comparator | Usual emergency department practice with physician-directed diagnostic testing Receives: Other: Usual emergency department practice with physician-directed diagnostic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients tested positive for SARS-CoV2 amongst the flow of consulting adults
Measured: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Secondary outcomes (8)
Proportion of positive patients amongst asymptomatic patients and in the Paris Metropolitan area at the same period (these proportions will be compared amongst each ED geographic area, amongst symptomatic patients and amongst the tested population)
Measured: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Feasibility of screening strategy : proportion of patients having completed the questionnaire, proportion of tests offered , accepted and performed, proportion of patients notified of the result and staff involved
Measured: At the end of the expected duration of the study (2 months and 15±10 days + wash out in each ED)
Description of patients tested in both periods (proportion of positive tests and of asymptomatic patients)
Measured: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
For symptomatic patients: description of the symptomatology
Measured: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Description of patients tested in both periods: patient exposure factors with the DEPIST-COVID questionnaire
Measured: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Sociodemographic, behavioural factors and habits associated with SARS-Cov2 infection in patients tested in the following schemes: DEPIST-COVID, ComCor and COVISAN .
Measured: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Incidence of SARS-Cov2 infections in Paris Metropolitan area : proportion of positive patients and their profiles. To estimate the under-detection of cases in the region, and compare with results from the model experiment .
Measured: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Number of close contact persons who have been tested for SARS-Cov2, who have been tested positive and who have been isolated over both periods.
Measured: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start12 Mar 2021
- Primary completion31 May 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 138,352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith LEBLANC, RN, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756609
- Sponsor's protocol ID
- APHP201625
- Other IDs
- IDRCB: 2020-A03532-37
- Acronym
- DEPIST-COVID
- Status last verified
- Oct 2023
- First submitted
- 6 Feb 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data are owned by the Assistance Publique - Hôpitaux de Paris (AP-HP) sponsor, "Département de la Recherche Clinique et du Développement". The data are not freely available. No data may be transmitted unless a contract has first been signed between the AP-HP and an external partner interested in the data. For all inquiries, please contact the following: DJENNAOUI Fatiha \<fatiha.djennaoui@aphp.fr\> and \[DRC\] Secretariat Promotion Délégation à la Recherche Clinique et à l'Innovation \<drc-secretariat-promotion@aphp.fr\>.
Publications
Leblanc J, Dusserre-Telmon L, Chauvin A, Simon T, Sabbatini CE, Hemming K, Colizza V, Berard L, Convert J, Lazazga S, Jegou C, Taibi N, Dautheville S, Zaghia D, Gerlier C, Domergue M, Larrouturou F, Bonnet F, Fontanet A, Salhi S, LeGoff J, Cremieux AC; DEPIST-COVID group; FHU IMPEC (Improving Emergency Care) group. Intensified screening for SARS-CoV-2 in 18 emergency departments in the Paris metropolitan area, France (DEPIST-COVID): A cluster-randomized, two-period, crossover trial. PLoS Med. 2023 Dec 7;20(12):e1004317. doi: 10.1371/journal.pmed.1004317. eCollection 2023 Dec.
PubMed 38060611
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefit of a Systematic Offer of Nurse-Driven SARS-Cov2 Screening by Rapid Testing in Emergency Departments in the Paris Metropolitan Area
- ClinicalTrials.gov ID
- NCT04756609
- Acronym / sponsor ID
- DEPIST-COVID / APHP201625
- Conditions
- SARS-CoV Infection, Nurse's Role
- Keywords
- SARS-CoV-2, Mass screening, Emergency service, hospital Nurses, Prevention and control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138,352 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 16 Feb 2021 (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.
European countries faced another wave of the SARS-CoV2 pandemic, which has led to a second lockdown in France in November 2020 in order to avoid overwhelming health services. To prevent or reduce another wave, the strategy calls for vaccination, maintaining barrier measures and testing and isolating infected persons in order to break the cycles of infection. The latter objective is made difficult by the existence of asymptomatic carriers or symptomatic carriers that have very few symptoms and that aren't tested. Identification of these carriers in the general population is usually based on a search for close contact persons from those who were tested positive or from identified clusters.
Experiments of mass testing are being carried out or were carried out, for example in Liverpool or Slovakia but, in order for them to be effective, they must be repeated, which limits feasibility. Another strategy of wide screening in the general population to identify asymptomatic persons is to offer a systematic screening during medical consultations and particularly in the emergency departments (ED). This strategy grants access to the entire population attending health facilities, including persons with lower income. This strategy can be conducted continuously in order to: 1) contribute to controlling the epidemic by identifying and isolating asymptomatic persons and their close contacts; 2) provide an observatory on the evolution of viral circulation in the general population.
To the best the knowledge, this strategy has not been evaluated and will be tested it in 18 emergency departments in the Paris Metropolitan area, one of the most SARS-CoV2 affected regions.
The aim is to evaluate the benefit of a systematic offer of SARS-Cov2 screening by rapid testing (molecular multiplex PCR/ RT-LAMP) to identify infected persons, associated with the usual practice of the EDs (intervention strategy) compared to a period based on usual practice of the EDs (control strategy)
The strategies will be compared during two periods following a cluster-randomized two-period crossover design.
During intervention periods, nurses will suggest performing a SARS-CoV2 test to patients using a PCR multiplex for symptomatic patients and a RT-LAMP for asymptomatic patients.
Detailed description
European countries faced another wave of the SARS-CoV2 pandemic, which has led to a lockdown in France in November 2020 in order to avoid overwhelming health services. To prevent or reduce another wave, the strategy calls for vaccination, maintaining barrier measures and testing and isolating infected persons in order to break the cycles of infection. The latter objective is made difficult by the existence of asymptomatic carriers or symptomatic carriers that have very few symptoms and that aren't tested. Identification of these carriers in the general population is usually based on a search for close contact persons from those who were tested positive or from identified clusters.
Experiments of mass testing are being carried out or were carried out, for example in Liverpool or Slovakia but, in order for them to be effective, they must be repeated, which limits feasibility. Another strategy of wide screening in the general population to identify asymptomatic persons is to offer a systematic screening during medical consultations and particularly in the emergency departments (ED). This strategy grants access to the entire population attending health facilities, including persons with lower income. This strategy can be conducted continuously in order to: 1) contribute to controlling the epidemic by identifying and isolating asymptomatic persons and their close contacts; 2) provide an observatory on the evolution of viral circulation in the general population.
To the best of the knowledge, this strategy has not been evaluated and will be tested it in 18 emergency departments in the Paris Metropolitan area (Ile-de-France), one of the most SARS-CoV2 affected regions.
The primary objective is to evaluate the benefit of a systematic offer of nurse-driven SARS-Cov2 screening by rapid testing (molecular multiplex PCR/ RT-LAMP) to identify infected persons, associated with the usual practice of the EDs (intervention strategy) compared to a period based on usual practice of the EDs (control strategy).
The primary outcome is the proportion of patients tested positive for SARS-CoV2 amongst the flow of consulting adults.
The secondary outcomes are to:
- compare the proportion of patients tested positive for SARS-CoV2 amongst asymptomatic patients tested in the Paris Metropolitan area at the same period (the comparison will also be done amongst the geographical area of each ED, amongst symptomatic patients tested and also amongst the entire tested population)
- evaluate the feasibility of the screening strategy
- describe the patients tested for SARS-Cov2 in both periods :
- proportion of positive tests
- proportion of asymptomatic patients amongst tested patients and amongst SARS-Cov2 positive patients
- For the symptomatic patients tested positive : symptomology
- Patient exposure factors with the DEPIST-COVID questionnaire and according to SARS-Cov2 test result.
- describe socio-demographic and behavioral factors and habits associated with SARS-Cov2 infection in patients tested in one of the following schemes: DEPIST-COVID, ComCor (Pasteur Institute) and COVISAN.
- estimate the incidence of new SARS-Cov2 infections in the Paris Metropolitan area: proportion of positive patients and their profiles. To estimate the under-detection of cases in the region, and compare with results from the model experiment.
- estimate the number of close contact persons who have been tested for SARS-Cov2, who have been tested positive and who have been isolated over both periods.
Methods The strategies will be compared during two periods in 18 EDS of Paris metropolitan area following a cluster-randomized two-period crossover design. Each period will last 1 month. Patients will participate to a follow-up call (within 15 days ±10). The periods will be separated by an expected period of washout of a minimum of 1 day .
During intervention periods, nurses will suggest performing a SARS-CoV2 test to patients. According to the answers to a self-administered questionnaire, a PCR multiplex will be performed for symptomatic patients and a RT-LAMP for asymptomatic patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systematic offer of nurse-driven SARS-CoV-2 screening + usual practice | Experimental | Procedure: Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practiceSystematic offer of nurse-driven SARS-CoV-2 screening combined with usual practice |
| Control group: Usual emergency department practice | Active comparator | Other: Usual emergency department practice with physician-directed diagnostic testingUsual emergency department practice with physician-directed diagnostic testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consulting adults visiting a participating ED
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practiceI- A SARS-CoV2 self-administered questionnaire about SARS-CoV2 symptoms, possibilities of close contacts, risk exposure situations and socio-demographic characteristics will be offered to patients included who are capable of filling it out. * The patient will fill out the questionnaire and hand it in to the nurse caring for him/her. * The nurse, regardless of the answers to the questionnaire, will offer the SARS-CoV2 screening. * A nasopharyngeal swab for SARS-CoV2 will be carried out. * A patient will be considered as symptomatic if he/she presents one or more symptoms listed in the questionnaire. * For symptomatic patients, a SARS-CoV2 for multiplex PCR will be carried out. This analysis takes 75 minutes. * For asymptomatic patients, a RT-LAMP test will be carried out. This analysis takes 5 to 15 minutes. | Procedure or surgery | Systematic offer of nurse-driven SARS-CoV-2 screening + usual practice |
| Usual emergency department practice with physician-directed diagnostic testingThe physician offers a SARS-CoV2 test according to current recommendations. The tests are prescribed as a means of diagnosis for patients presenting symptoms suggestive of Covid-19 or as a means of diagnosis for patients requiring hospitalisation for another cause, before their transfer to hospital. Patients will be cared for according to usual procedures of each hospital. Patients tested positive will be asked to fill out the DEPIST-COVID questionnaire. Patients who had not completed it will be contacted by phone to answer the questions over the phone. | Other | Control group: Usual emergency department practice |
Primary outcome
Proportion of patients tested positive for SARS-CoV2 amongst the flow of consulting adults
Time frame: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
8 secondary outcomes
Proportion of positive patients amongst asymptomatic patients and in the Paris Metropolitan area at the same period (these proportions will be compared amongst each ED geographic area, amongst symptomatic patients and amongst the tested population)
Time frame: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Feasibility of screening strategy : proportion of patients having completed the questionnaire, proportion of tests offered , accepted and performed, proportion of patients notified of the result and staff involved
Time frame: At the end of the expected duration of the study (2 months and 15±10 days + wash out in each ED)
Description of patients tested in both periods (proportion of positive tests and of asymptomatic patients)
Time frame: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
For symptomatic patients: description of the symptomatology
Time frame: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Description of patients tested in both periods: patient exposure factors with the DEPIST-COVID questionnaire
Time frame: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Sociodemographic, behavioural factors and habits associated with SARS-Cov2 infection in patients tested in the following schemes: DEPIST-COVID, ComCor and COVISAN .
Time frame: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Incidence of SARS-Cov2 infections in Paris Metropolitan area : proportion of positive patients and their profiles. To estimate the under-detection of cases in the region, and compare with results from the model experiment .
Time frame: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Number of close contact persons who have been tested for SARS-Cov2, who have been tested positive and who have been isolated over both periods.
Time frame: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 38060611Leblanc J, Dusserre-Telmon L, Chauvin A, Simon T, Sabbatini CE, Hemming K, Colizza V, Berard L, Convert J, Lazazga S, Jegou C, Taibi N, Dautheville S, Zaghia D, Gerlier C, Domergue M, Larrouturou F, Bonnet F, Fontanet A, Salhi S, LeGoff J, Cremieux AC; DEPIST-COVID group; FHU IMPEC (Improving Emergency Care) group. Intensified screening for SARS-CoV-2 in 18 emergency departments in the Paris metropolitan area, France (DEPIST-COVID): A cluster-randomized, two-period, crossover trial. PLoS Med. 2023 Dec 7;20(12):e1004317. doi: 10.1371/journal.pmed.1004317. eCollection 2023 Dec.
- Individual participant dataSharing planned: No. The study data are owned by the Assistance Publique - Hôpitaux de Paris (AP-HP) sponsor, "Département de la Recherche Clinique et du Développement". The data are not freely available. No data may be transmitted unless a contract has first been signed between the AP-HP and an external partner interested in the data. For all inquiries, please contact the following: DJENNAOUI Fatiha <fatiha.djennaoui@aphp.fr> and [DRC] Secretariat Promotion Délégation à la Recherche Clinique et à l'Innovation <drc-secretariat-promotion@aphp.fr>.
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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.
Judith LEBLANC, RN, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practice and Usual emergency department practice with physician-directed diagnostic testing in people with SARS-CoV Infection and Nurse's Role, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients tested positive for SARS-CoV2 amongst the flow of consulting adults (time frame: At the end of the expected duration of the inclusion period (an average of 3 months in each ED)). 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 NCT04756609, which also lists 1 linked publication.
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 10 Oct 2023.