COVID-19 - Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus
- Conditions
- Infection Viral
- Registration Number
- NCT04290780
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2162
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 :
- 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
- Anyone who does not meet the above definition.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method nosocomial infection At inclusion The primary outcome criteria will be the proportion of patients, caregivers and health care professionals with confirmed or suspected SARS-CoV-2 nosocomial infection relative to all patients, caregivers and health care professionals with syndromes suggestive of SARS-CoV-2 infection during the study period. The infection control measures will be reported and describe according the nosocomial cases.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Service Hygiène, Epidémiologie et Prévention
🇫🇷Lyon, France