NOsocomial Dissemination Risk of SARS-Cov2 (NODS-Cov2)

November 19, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2523

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Garches, France
        • Didier Guillemot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Working caregivers and hospitalized patients in care services dedicated or not to SARS Cov2 (including resuscitation services) in both adult and pediatric hospitals. Investigator will be interested in both adult and child services because the latter present a pauci-symptomatic form so the dynamics of transmission can be different.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding the dissemination of SARS Cov2 in hospital
Time Frame: 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
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Optimizing hospital strategies to prevent transmission to caregivers and not infected hospitalized patients with SARSCov2
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2020

Primary Completion (Actual)

July 10, 2020

Study Completion (Actual)

July 12, 2020

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • APHP200417

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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