CaregiversEMBELLIENCT04376944
Barrier Measures to Limit Covid-19.Nosocomial Transmission: a Cross-sectional Evaluation
An observational study of Caregivers and COVID-19, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Use lay language. The Covid-19 pandemic hit France in March 2020 and stage 3 of the epidemic justified the introduction of national and unprecedented containment measures from March 17, 2020. The Montpellier CHU experienced peak hospitalizations of Covid-19 infections in late March. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers, COVID-19
- What is being tested?
- Survey
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 30 Dec 2020
- Phase
- Observational
- 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
Study population: carers of the UH Montpellier
Who may be able to join
- exposed group: exposed caregivers and agents who worked in COVID units (medicine, resuscitation, screening) until their date of collection. An exposed agent or caregiver is defined by the entrance of rooms with a COVID-19 infection during their professional activity.
- low or unexposed group: caregivers or agents who have worked in non-COVID units in a non-COVID hospital
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
Marie Bistoquet, MD contact
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34295
Marie Bistoquet, MB, m-bistoquet@chu-montpellier.fr
About this study
Official title: Evaluating Effectiveness of Barrier Measures to Limit Nosocomial Transmission: Covid-19 Prevalence Survey Among Caregivers With Various Exposures
Use lay language. The Covid-19 pandemic hit France in March 2020 and stage 3 of the epidemic justified the introduction of national and unprecedented containment measures from March 17, 2020. The Montpellier CHU experienced peak hospitalizations of Covid-19 infections in late March. The estimate of the proportion of infected people in Occitania, South of France, for the 11th of May 2020 is 3.1% (95% CI: 1.9-5.9) for the Occitania region, to which Montpellier belongs.
In the context of the Covid-19 epidemic, notably due to the absence of pharmacological or vaccine prophylaxis, barrier measures were of crucial importance, especially for exposed caregivers. These measures include an adaptation of individual behavior, the creation of a so-called "Covid" hospital, the wearing of specific equipment in all departments, the use in the rooms of Covid-19 patients of a gown, an apron, gloves, and a FFP2 type mask in the event of contact and sampling, protocolized and standardized bio-cleaning measures, a reorganization of the premises and the definition of specific circuits.
Read more
In view of the second wave of the epidemic, estimating the effectiveness of the barrier measures is of major importance. The investigators therefore propose an evaluation of the effectiveness of these measures, by comparing the serological prevalence of infection among caregivers working directly in COVID units compared to caregivers working in services excluding the management of Covid-19 patients.
Systematic evaluation in COVID-19 units of Sarc-Co-V2 infection will also be assessed, with naso-pharyngeal swabs.
- Conditions
- Caregivers, COVID-19
- Being tested
- Survey
- Keywords
- barrier measures
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
questionnaire on their symptoms and their exposures
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Caregivers and agents working directly in COVID units compared to those living. Receives: Other: Survey | |
| Control group | caregivers anf agents working in services excluding the management of patients screened positive for Covid-19 infection Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of caregivers and agents with a positive serodiagnosis
Proportion of caregivers and agents with a positive serodiagnosis in COVID units versus non-COVID units
Measured: 1 day
Secondary outcomes (1)
Proportion of caregivers and agents with a positive RT-PCR
Proportion of caregivers and agents with a positive RT-PCR in COVID units versus non-COVID units
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Apr 2020
- Primary completion1 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Bistoquet, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376944
- Sponsor's protocol ID
- RECHMPL20_0261
- Acronym
- EMBELLIE
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effectiveness of Barrier Measures to Limit Nosocomial Transmission: Covid-19 Prevalence Survey Among Caregivers With Various Exposures
- ClinicalTrials.gov ID
- NCT04376944
- Acronym / sponsor ID
- EMBELLIE / RECHMPL20_0261
- Conditions
- Caregivers, COVID-19
- Keywords
- barrier measures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 6 May 2020 (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.
Use lay language. The Covid-19 pandemic hit France in March 2020 and stage 3 of the epidemic justified the introduction of national and unprecedented containment measures from March 17, 2020. The Montpellier CHU experienced peak hospitalizations of Covid-19 infections in late March. The estimate of the proportion of infected people in Occitania, South of France, for the 11th of May 2020 is 3.1% (95% CI: 1.9-5.9) for the Occitania region, to which Montpellier belongs.
In the context of the Covid-19 epidemic, notably due to the absence of pharmacological or vaccine prophylaxis, barrier measures were of crucial importance, especially for exposed caregivers. These measures include an adaptation of individual behavior, the creation of a so-called "Covid" hospital, the wearing of specific equipment in all departments, the use in the rooms of Covid-19 patients of a gown, an apron, gloves, and a FFP2 type mask in the event of contact and sampling, protocolized and standardized bio-cleaning measures, a reorganization of the premises and the definition of specific circuits.
In view of the second wave of the epidemic, estimating the effectiveness of the barrier measures is of major importance. The investigators therefore propose an evaluation of the effectiveness of these measures, by comparing the serological prevalence of infection among caregivers working directly in COVID units compared to caregivers working in services excluding the management of Covid-19 patients.
Systematic evaluation in COVID-19 units of Sarc-Co-V2 infection will also be assessed, with naso-pharyngeal swabs.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Other: SurveyCaregivers and agents working directly in COVID units compared to those living. |
| Control group | – | Other: Surveycaregivers anf agents working in services excluding the management of patients screened positive for Covid-19 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- carers of the UH Montpellier
Key inclusion criteria (2 listed)
- exposed group: exposed caregivers and agents who worked in COVID units (medicine, resuscitation, screening) until their date of collection. An exposed agent or caregiver is defined by the entrance of rooms with a COVID-19 infection during their professional activity.
- low or unexposed group: caregivers or agents who have worked in non-COVID units in a non-COVID hospital
Key exclusion criteria (1 listed)
- refusal to participate
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 |
|---|---|---|
| Surveyquestionnaire on their symptoms and their exposures | Other | Control group, Exposed group |
Primary outcome
Proportion of caregivers and agents with a positive serodiagnosis
Time frame: 1 day
Proportion of caregivers and agents with a positive serodiagnosis in COVID units versus non-COVID units
1 secondary outcome
Proportion of caregivers and agents with a positive RT-PCR
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Marie Bistoquet, MD contact
Marie Bistoquet, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregivers and COVID-19, run by University Hospital, Montpellier 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 2 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: status not confirmed, as of the sponsor's last update on 6 May 2020. 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?
Contact Alain MAKINSON, MCU-PH (0663075260 ext. 33, a-makinson@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of caregivers and agents with a positive serodiagnosis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2020.