Clinical trial NCT04290780: COVID-19 - Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus
Official title: Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection Viral
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 2162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will focus on volunteers, patients, caregivers and health care professionals within the participating hospitals associated with the GABRIEL network. Other hospitals, including french, will be able to integrate with this project on a voluntary basis.

Brief summary: Infection with the SARS-CoV-2 coronavirus strain is associated with severe morbidity and mortality estimated today from 2% to 4%. Elderly patients or patients with serious chronic conditions justifying hospitalization are particularly at risk. The risk of infection with SARS-CoV-2 during hospitalization is also substantial and increased in fragile patients. Several cases of infection among Healthcare Professionals had been reported.

The hypothesis is that similar to the corona virus agent responsible for SRAS and the influenza virus, nosocomial outbreaks of SARS-CoV-2 to be feared. Health care professionals and caregivers are populations-at-risk as they are exposed in the community and can transmit SARS-CoV-2 to hospitalized patients, and are also exposed to hospitalized patients infected with SARS-CoV-2.

Describing hospital-acquired cases and SARS-CoV-2 infection transmission chains in healthcare settings is vitally essential to achieve control of this epidemic. To improve the quality of care and patient safety, this data must be accompanied by an analysis of the impact of infection control measures. In addition, an effective infection control program is urgently required to control the spread of the virus and protect both uninfected patients who require care for other medical or surgical conditions as well as health care professionals.

The main objective of this prospective, non-interventional - observational, hospital based study in adults and children is to describe and document suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective factors) at participating hospitals.

Characterization of the clinical features of the SARS-CoV-2 infection will help to identify potential sources of virus transmission as rapidly as possible and enable implementation of appropriate hygiene practices in hospitals.


Eligibility criteria: Inclusion Criteria:

1 ) Any adult or child or member of the nursing staff from the study participant hospital who presents an infectious syndrome including the following definition :

2) Suspect Case:

Fever above 37.8 ° C if no antipyretics are taken; And or Cough or pharyngeal pain or other symptom suggestive of respiratory infection. AND at least 1 of the following characteristics:

* return from a trip to China, or to a country in which the increase in the incidence of infections in SARS-CoV-2 has been proven;
* close contact (sharing the same place of family, professional life, same plane, etc.) with a person defined as a suspected or confirmed case;
* Occurring in an establishment having received at least one case of suspected or confirmed infection at SARS-CoV-2.

Or 3) Confirmed Case: The same clinical definitions, in addition to a positive RT-PCR-type virological diagnostic result specific to SARS-CoV-2

Exclusion Criteria:

* Anyone who does not meet the above definition.

Primary outcomes:
measure: nosocomial infection
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service Hygiène, Epidémiologie et Prévention
city: Lyon
country: France
facility: Service Hygiène, Epidémiologie et Prévention
Study officials:
affiliation: Service Hygiène, Epidémiologie et Prévention
name: Philippe VANHEMS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanhems P. A breath of humanity in the era of Covid-19 vaccine. Vaccine. 2021 Jun 23;39(28):3649. doi: 10.1016/j.vaccine.2021.05.052. Epub 2021 May 24. No abstract available.
citation: Saadatian-Elahi M, Picot V, Henaff L, Pradel FK, Escuret V, Dananche C, Elias C, Endtz HP, Vanhems P. Protocol for a prospective, observational, hospital-based multicentre study of nosocomial SARS-CoV-2 transmission: NOSO-COR Project. BMJ Open. 2020 Oct 22;10(10):e039088. doi: 10.1136/bmjopen-2020-039088.