NOsocomial Dissemination Risk of SARS-Cov2

Sars-CoV2 Clinical Trial

— NODS-Cov2  

Official title:

NOsocomial Dissemination Risk of SARS-Cov2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04339881
• Other study ID #: APHP200417
• Status: Completed
• Start date: April 17, 2020
• Est. completion date: July 12, 2020

Study information

• Verified date: April 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2523
• Est. completion date: July 12, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sars-CoV2

Locations

Country	Name	City	State
France	Didier Guillemot	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understanding the dissemination of SARS Cov2 in hospital	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	Optimizing hospital strategies to prevent transmission to caregivers and not infected hospitalized patients with SARSCov2		8 weeks