Coronavirus Infectious Disease (COVID-19)NOSOCOVIDNCT04659356
NOSOcomial COVID-19 in ICU (NOSOCOVID)
An observational study of Coronavirus Infectious Disease (COVID-19) and Nosocomial Infection, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infectious Disease (COVID-19), Nosocomial Infection, Nosocomial COVID-19
- What is being tested?
- Patients admitted in Intensive Care Units
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 14 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in ICU and Healthcare workers working in ICU
Who may be able to join
- 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)
Who cannot join
- Refusal to participate in research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, 44000
GARRET Charlotte, MD, 0240084737, charlotte.garret@chu-nantes.fr
GARRET Charlotte, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Patients admitted in Intensive Care Units
- Keywords
- Coronavirus Infectious Disease (COVID-19), Nosocomial Infection, SARS-Coronavirus-2, Intensive Care Units (ICU), Personal protective equipment
- Medical subject headings
- COVID-19, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients admitted in Intensive Care UnitsOther
Data will be collected computerized patient records by the clinicians in charge of the patient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patients admitted in Intensive Care Units |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 10 months
Secondary outcomes (2)
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).
Measured: up to 10 months
evaluate the occurence
- ICU nosocomial infections rates (ventilator associated acquired pneumonia)
- Highly resistant bacteria colonization and infection acquired in ICU
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Sep 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion14 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Infectious Disease (COVID-19)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659356
- Sponsor's protocol ID
- MR_NOSOCOVID
- Acronym
- NOSOCOVID
- Status last verified
- Mar 2021
- First submitted
- 8 Dec 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a SARS-CoV-2 Infectious Risk Management Protocol on the Transmission of Nosocomial COVID in Intensive Care Unit"
- ClinicalTrials.gov ID
- NCT04659356
- Acronym / sponsor ID
- NOSOCOVID / MR_NOSOCOVID
- Keywords
- Coronavirus Infectious Disease (COVID-19), Nosocomial Infection, SARS-Coronavirus-2, Intensive Care Units (ICU), Personal protective equipment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 14 Jul 2021 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted in Intensive Care Units | – | Other: Patients admitted in Intensive Care UnitsAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU and Healthcare workers working in ICU
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Refusal to participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients admitted in Intensive Care UnitsData will be collected computerized patient records by the clinicians in charge of the patient. | Other | Patients admitted in Intensive Care Units |
Primary outcome
Incidence of nosocomial COVID-19
Time frame: up to 10 months
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.
2 secondary outcomes
Occurrence of a nosocomial COVID-19 that is certain and Occurrence of a nosocomial COVID-19 that is probable.
Time frame: up to 10 months
evaluate the occurence
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infectious Disease (COVID-19) and Nosocomial Infection, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GARRET Charlotte (0240084737, charlotte.garret@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of nosocomial COVID-19 (time frame: up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.