NOSOcomial COVID-19 in ICU (NOSOCOVID)

Nosocomial Infection Clinical Trial

— NOSOCOVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04659356
• Other study ID #: MR_NOSOCOVID
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: July 14, 2021

Study information

• Verified date: March 2021
• Source: Nantes University Hospital
• Contact: GARRET Charlotte
• Phone: 0240084737
• Email: charlotte.garret[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 14, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infections
• Coronavirus Infectious Disease (COVID-19)
• Cross Infection
• Infection
• Nosocomial COVID-19
• Nosocomial Infection

Intervention

Other:
• Patients admitted in Intensive Care Units
Data will be collected computerized patient records by the clinicians in charge of the patient.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	evaluate the occurence	ICU nosocomial infections rates (ventilator associated acquired pneumonia); Highly resistant bacteria colonization and infection acquired in ICU	up to 12 months