NCT04659356

NOSOcomial COVID-19 in ICU (NOSOCOVID)

Evaluation of a SARS-CoV-2 Infectious Risk Management Protocol on the Transmission of Nosocomial COVID in Intensive Care Unit"

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current global pandemic at COVID-19 is a major public health issue. Transmission of the virus is primarily through direct and close person-to-person contact. The protection of health care personnel and the limitation of transmission of nosocomial COVID is paramount. Protective measures have already shown their effectiveness in limiting the spread of the virus: the use of masks, the wearing of protective gowns, the wearing of protective eyewear, social and physical distancing. A recent U.S. study (Rhee et al. JAMA 2020) reported a very low incidence of 1.7% of nosocomial COVID, but this was achieved with the application of rigorous infection risk management protocols. In addition to the widespread use of masks and protective measures, dedicated COVID units had been created, with air treatment. The implementation of these dedicated units requires the mobilization of considerable human and material resources, which is not feasible in all hospitals over the long term. In view of the second wave of the epidemic in France, with the rising numbers of new cases of COVDI-19 admitted to intensive care units since the end of the summer 2020, it is essential to organize the intensive care units to ensure the protection of personnel and limit the risk of nosocomial COVID-19, while continuing to care for non-COVID patients. In Intensive Care unit (ICU) at the Nantes University Hospital, a strict protocol for the management of suspected or confirmed COVID patients has been in place since early september 2020. The objective of this study is to evaluate the effectiveness of this protocol for managing the infectious risk of SARS-COV-2 on the incidence of nosocomial COVID in patients admitted in ICU. The secondary objectives are to evaluate the incidence of nosocomial-associated COVIDs contracted by caregivers, and the incidence of asymptomatic positive SARS-CoV-2 cases in ICU.

Detailed description

All patients admitted in our ICU since august 2020 were enrolled in the study, after they have been informed and given their consent for their participation in this observational study. Data will be collected computerized patient records by the clinicians in charge of the patient. Because of variants emergence, the investigators decided to had a second period from march to july. The investigators anticipate an inclusion of approximately 1000 patients. In an observational study, there is no risk to the patient

Conditions

• Coronavirus Infectious Disease (COVID-19)
• Nosocomial Infection
• Nosocomial COVID-19

Interventions

Type	Name	Description
OTHER	Patients admitted in Intensive Care Units	Data will be collected computerized patient records by the clinicians in charge of the patient.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-07-01
• Completion: 2021-07-14
• First posted: 2020-12-09
• Last updated: 2021-03-23

Locations

1 site across 1 country: France