- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04376944
Barrier Measures to Limit Covid-19.Nosocomial Transmission: a Cross-sectional Evaluation (EMBELLIE)
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.
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.
Studieöversikt
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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-
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Montpellier, Frankrike, 34295
- Rekrytering
- UH Montpellier
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Kontakt:
- Marie Bistoquet, MB
- E-post: m-bistoquet@chu-montpellier.fr
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Exposed group
Caregivers and agents working directly in COVID units compared to those living.
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questionnaire on their symptoms and their exposures
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Control group
caregivers anf agents working in services excluding the management of patients screened positive for Covid-19 infection
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questionnaire on their symptoms and their exposures
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Proportion of caregivers and agents with a positive serodiagnosis
Tidsram: 1 day
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Proportion of caregivers and agents with a positive serodiagnosis in COVID units versus non-COVID units
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1 day
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Proportion of caregivers and agents with a positive RT-PCR
Tidsram: 1 day
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Proportion of caregivers and agents with a positive RT-PCR in COVID units versus non-COVID units
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1 day
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Marie Bistoquet, MD, University Hospital, Montpellier
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RECHMPL20_0261
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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