NCT04290780

COVID-19 - Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus

Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,162 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Infection Viral

Interventions

Type	Name	Description
OTHER	nosocomial infection/hospital acquired infection	When there is suspicion of a community-acquired case (admission of an infected patient) or nosocomial case (infection of a patient already hospitalized), a case report form including demographic data, medical history, and clinical and biological data on the infectious episode will be completed for each case, either patient, caregivers or health care professionals, presenting clinical signs or symptoms compatible with SARS-CoV-2 infection. The suspected cases will undergo nasopharyngeal swab collection and detection of SARS-CoV-2 in nasopharyngeal swabs will be done by real-time RT-PCR assay. Hygiene measures applied by the service will be collected using a questionnaire as well as recommendations of the learned societies within the country regarding the risk of infection by coronavirus. In addition, data characterizing the service and hospital will also be collected (specialty, number of beds, number of nurses, doctors, etc.).

Timeline

• Start date: 2020-03-09
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2020-03-02
• Last updated: 2025-09-02

Locations

2 sites across 1 country: France