NOSOcomial COVID-19 in ICU (NOSOCOVID) (NOSOCOVID)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nosocomial Infection; Coronavirus Infectious Disease (COVID-19); Nosocomial COVID-19
• Intervention / Treatment: Other: Patients admitted in Intensive Care Units

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

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: GARRET Charlotte; Phone Number: 0240084737; Email: charlotte.garret@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44000
    • Recruiting
    • Nantes University Hospital
    • Principal Investigator: GARRET Charlotte, MD
    • Sub-Investigator: REIGNIER Jean, PHd
    • Sub-Investigator: CANET Emmanuel, PHd
    • Sub-Investigator: LASCARROU Jean-Baptiste, MD
    • Sub-Investigator: MARTIN Maelle, MD
    • Sub-Investigator: LEMARIE Jeremy, MD
    • Sub-Investigator: BOURIGAULT Celine, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted in ICU and Healthcare workers working in ICU

Description

Inclusion Criteria:

• All Patients admitted in ICU during the inclusion period (Nantes University Hospital)
• AND all Healthcare workers working in ICU during the inclusion period (Nantes University Hospital)

Exclusion Criteria:

• Refusal to participate in research

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients admitted in Intensive Care Units; All patients admitted in our ICU since august were enrolled in our study, after they have been informed and given their consent for their participation in this observational study.	Other: Patients admitted in Intensive Care Units; Data will be collected computerized patient records by the clinicians in charge of the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of nosocomial COVID-19	Occurence of a nosocomial COVID-19 that is certain or probable. Community-acquired certain and probable COVIDs will be excluded from the main analysis. The incidence rate of nosocomial COVID will be expressed in patient-days: Ratio of the number of patients with nosocomial COVID to the sum of exposure times, i.e. : for patients without nosocomial COVID: duration of hospitalization in ICU; for patients presenting with nosocomial COVID: delay between the date of the start of hospitalization in ICU and the occurrence of nosocomial COVID.	up to 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of a nosocomial COVID-19 that is certain and Occurrence of a nosocomial COVID-19 that is probable.	Prevalence of community-acquired COVID that is certain and Prevalence of community-acquired COVID that is probable. Prevalence of nosocomial and community-acquired COVID in healthcare workers. Prevalence will be defined as the ratio of the number of caregivers developing a COVID to the number of caregivers working in ICU during the inclusion period. Prevalence of patients with SARS-CoV-2 positive samples but asymptomatic in ICU. Risk factors to development a nosocomial COVID (certain and probable).	up to 10 months
evaluate the occurence	ICU nosocomial infections rates (ventilator associated acquired pneumonia); Highly resistant bacteria colonization and infection acquired in ICU	up to 12 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 14, 2021

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Personal protective equipment; Nosocomial Infection; Coronavirus Infectious Disease (COVID-19); SARS-Coronavirus-2; Intensive Care Units (ICU)
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Iatrogenic Disease; COVID-19; Coronavirus Infections; Infections; Communicable Diseases; Cross Infection
• Other Study ID Numbers: MR_NOSOCOVID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No