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NODS-Cov2: NOsocomial Dissemination Risk of SARS-Cov2

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT04339881
Collaborator
(none)
2,523
Enrollment
1
Location
2.8
Actual Duration (Months)
893
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To date, in France, in the context of the SARS Cov2 pandemic,both the number of affected subjects and the number of severe forms requiring hospital care are increasing.

Several nosocomial transmission clusters have already been identified in hospitals (both pediatric and adult) but there is still limited data on the nosocomial spread of SARS-Cov2.

This nosocomial transmission affects both patients and caregivers. It is important to understand the spread of the virus within the hospital. This will help to optimize procedures to prevent transmission to caregivers and hospitalizedpatients not infected with SARS Cov2, and more generally this will contribute to control the spread of SARS Cov2 in the community

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    It is an observational study without any risk. Every participating service will be investigated for 2 consecutive days .

    • At each staff rotation, an individualsensorwill be provided toall thestaff(caregivers, administrative, students etc…) to be worn duringtheirworking hours. Also a sensor will be placed at each patient's bedside.

    • In addition, epidemiological data relating to socio-demographic characteristics, profession, protective measures will be collectedfrom hospitalstaff. Also, some data from the 'entrepot des données de santé" regarding individual carepathways in the hospitalwill be extracted.

    • A map of the unit, specifying the location of each patient will be made.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    2523 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    NOsocomial Dissemination Risk of SARS-Cov2
    Actual Study Start Date :
    Apr 17, 2020
    Actual Primary Completion Date :
    Jul 10, 2020
    Actual Study Completion Date :
    Jul 12, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Understanding the dissemination of SARS Cov2 in hospital [2 days]

      In each unit, during 2 days, Patients and all staff (caregivers, administrative, students…) will carry an individualsensorwhich will regularly measure the proximity between 2 sensors

    Secondary Outcome Measures

    1. Optimizing hospital strategies to prevent transmission to caregivers and not infected hospitalized patients with SARSCov2 [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria for patients:

    • Informed of the purpose of the study and having expressed his non-opposition or of a relative (if the patient's state of health does not allow it)

    • Hospitalized in one of the participating departments

    Inclusion criteria for hospital staff:

    • Informed of the objective of the study and having expressed his no opposition

    • Having daily contact with patients hospitalized in participating departments

    Inclusion criteria for patient visitors

    • Informed of the purpose of the study and having expressed his non-opposition

    • Having daily contacts with patients hospitalized in the participating departments

    Exclusion Criteria for evryone (patient, hospital staff and patients visitors) :
    • Refuse to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Didier Guillemot Garches France

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT04339881
    Other Study ID Numbers:
    • APHP200417
    First Posted:
    Apr 9, 2020
    Last Update Posted:
    Nov 23, 2020
    Last Verified:
    Apr 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 23, 2020