Barrier Measures to Limit Covid-19.Nosocomial Transmission: a Cross-sectional Evaluation

COVID-19 Clinical Trial

— EMBELLIE  

Official title:

Evaluating Effectiveness of Barrier Measures to Limit Nosocomial Transmission: Covid-19 Prevalence Survey Among Caregivers With Various Exposures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376944
• Other study ID #: RECHMPL20_0261
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2020
• Source: University Hospital, Montpellier
• Contact: Alain MAKINSON, MCU-PH
• Phone: 0663075260
• Email: a-makinson[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

• refusal to participate

Related Conditions & MeSH terms

• Caregivers
• COVID-19

Intervention

Other:
• Survey
questionnaire on their symptoms and their exposures

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day
Secondary	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	1 day