SARS CoV 2 InfectionCOVIDINNCT05567874
Nosocomial COVID-19 Infections in Patients Hospitalized at the Metz-Thionville Regional Hospital in 2021
An observational study of SARS CoV 2 Infection, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
The rate of nosocomial SARS-CoV2 infections found in the different studies since the beginning of the pandemic is very variable (<1% in hospitals in the USA to about 20% in a British hospital). Mortality related to these nosocomial SARS-CoV2 infections is higher than in the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- Nosocomial SARS-COV 2 Infection proportion
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2022to 31 Aug 2022
- 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: Hospitalized patients with Covid-19 infection
Who may be able to join
- Patients hospitalised at the CHR Metz-Thionville in medicine, surgery and obstetrics (MCO) or geriatric follow-up and rehabilitation care (SSR) units, in 2021 for a Covid-19 infection defined by the existence of a positive PCR result for SARS-CoV2 during the stay, or by the existence of an ICD10 code for COVID in the PMSI data of the health care establishment
Who cannot join
- Opposition to participate in the study after reading the patient information note.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proportion of Nosocomial COVID-19 Infections in Patients Hospitalized at the Metz-Thionville Regional Hospital in 2021
The rate of nosocomial SARS-CoV2 infections found in the different studies since the beginning of the pandemic is very variable (<1% in hospitals in the USA to about 20% in a British hospital). Mortality related to these nosocomial SARS-CoV2 infections is higher than in the general population. The risk factors identified for this nosocomial acquisition are multiple. We were confronted with nosocomial acquisitions and cluster situations in the services, without exhaustive data to measure these phenomena, and we lacked data to consider areas for improvement.
The objectives of this study are to determine the proportion of nosocomial SARS COV 2 infections in the total number of patients hospitalized with a Covid-19 infection at the CHR Metz-Thionville in 2021, and to describe the characteristics of this population.
- Conditions
- SARS CoV 2 Infection
- Being tested
- Nosocomial SARS-COV 2 Infection proportion
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nosocomial SARS-COV 2 Infection proportionOther
Proportion of Nosocomial SARS-COV 2 Infections in Patients Hospitalized at the Metz-Thionville Regional Hospital in 2021
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in 2021 during the first period | SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in April 2021 Receives: Other: Nosocomial SARS-COV 2 Infection proportion | |
| SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in 2021 during the second period | SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville from June to September 2021 Receives: Other: Nosocomial SARS-COV 2 Infection proportion | |
| SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in 2021 during the third period | SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in December 2021 Receives: Other: Nosocomial SARS-COV 2 Infection proportion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of hospital-acquired infections in patients hospitalised with a covid-19 infection
Several elements are taken into account: a) the time between entry into the establishment and the first positive SARS COV 2 PCR, b) the time between entry into the establishment and the appearance of the most frequent symptoms (fever, cough), if present in the patient, in the seven days preceding the first positive SARS COV 2 PCR, c) the existence of an epidemiological link with other infected patients, via contact in a double room with another case, and/or via hospitalisation in a department concerned by a cluster situation according to the Santé Publique France definition of May 2020 (identified on the basis of monitoring and surveillance data from the hygiene department).
Measured: up to 8 months after the third COVID-19 wave
Secondary outcomes (1)
Description of the nosocomial infected population
age, sex, hospital unit care, outcomes of stay, vaccination status, associated conditions (comorbidities according to Charlson score, obesity, pregnancy), existence of screening on admission, time to acquisition of nosocomial infection, number of negative SARS-COV 2 PCRs in the institution before the first positive PCR, type of variant, presence of symptoms (cough, fever), stay in a double room in the 14 days prior to infection, cluster status in the ward, length of stay after infection.
Measured: up to 8 months after the third COVID-19 wave
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start3 Jan 2022
- Primary completion31 Mar 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu LLORENS, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567874
- Sponsor's protocol ID
- 2022-09Obs-CHRMT
- Acronym
- COVIDIN
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 6 May 2023
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proportion of Nosocomial COVID-19 Infections in Patients Hospitalized at the Metz-Thionville Regional Hospital in 2021
- ClinicalTrials.gov ID
- NCT05567874
- Acronym / sponsor ID
- COVIDIN / 2022-09Obs-CHRMT
- Conditions
- SARS CoV 2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Oct 2022 (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 rate of nosocomial SARS-CoV2 infections found in the different studies since the beginning of the pandemic is very variable (<1% in hospitals in the USA to about 20% in a British hospital). Mortality related to these nosocomial SARS-CoV2 infections is higher than in the general population. The risk factors identified for this nosocomial acquisition are multiple. We were confronted with nosocomial acquisitions and cluster situations in the services, without exhaustive data to measure these phenomena, and we lacked data to consider areas for improvement.
The objectives of this study are to determine the proportion of nosocomial SARS COV 2 infections in the total number of patients hospitalized with a Covid-19 infection at the CHR Metz-Thionville in 2021, and to describe the characteristics of this population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in 2021 during the first period | – | Other: Nosocomial SARS-COV 2 Infection proportionSARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in April 2021 |
| SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in 2021 during the second period | – | Other: Nosocomial SARS-COV 2 Infection proportionSARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville from June to September 2021 |
| SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in 2021 during the third period | – | Other: Nosocomial SARS-COV 2 Infection proportionSARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in December 2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with Covid-19 infection
Key inclusion criteria (1 listed)
- Patients hospitalised at the CHR Metz-Thionville in medicine, surgery and obstetrics (MCO) or geriatric follow-up and rehabilitation care (SSR) units, in 2021 for a Covid-19 infection defined by the existence of a positive PCR result for SARS-CoV2 during the stay, or by the existence of an ICD10 code for COVID in the PMSI data of the health care establishment
Key exclusion criteria (1 listed)
- Opposition to participate in the study after reading the patient information note.
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 |
|---|---|---|
| Nosocomial SARS-COV 2 Infection proportionProportion of Nosocomial SARS-COV 2 Infections in Patients Hospitalized at the Metz-Thionville Regional Hospital in 2021 | Other | SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in 2021 during the first period, SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in 2021 during the second period, SARS-CoV 2 infected patients hospitalized at CHR Metz-Thionville in 2021 during the third period |
Primary outcome
Proportion of hospital-acquired infections in patients hospitalised with a covid-19 infection
Time frame: up to 8 months after the third COVID-19 wave
Several elements are taken into account: a) the time between entry into the establishment and the first positive SARS COV 2 PCR, b) the time between entry into the establishment and the appearance of the most frequent symptoms (fever, cough), if present in the patient, in the seven days preceding the first positive SARS COV 2 PCR, c) the existence of an epidemiological link with other infected patients, via contact in a double room with another case, and/or via hospitalisation in a department concerned by a cluster situation according to the Santé Publique France definition of May 2020 (identified on the basis of monitoring and surveillance data from the hygiene department).
1 secondary outcome
Description of the nosocomial infected population
Time frame: up to 8 months after the third COVID-19 wave
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
Mathieu LLORENS, MD principal investigator
CHR Metz Thionville Hopital de Mercy
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 SARS CoV 2 Infection, run by Centre Hospitalier Régional Metz-Thionville 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 1 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: finished, as of the sponsor's last update on 6 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of hospital-acquired infections in patients hospitalised with a covid-19 infection (time frame: up to 8 months after the third COVID-19 wave). 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 6 May 2023.