COVID-19 - Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus
NCT ID: NCT04290780
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2162 participants
OBSERVATIONAL
2020-03-09
2020-06-30
Brief Summary
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The hypothesis is that similar to the corona virus agent responsible for SRAS and the influenza virus, nosocomial outbreaks of SARS-CoV-2 to be feared. Health care professionals and caregivers are populations-at-risk as they are exposed in the community and can transmit SARS-CoV-2 to hospitalized patients, and are also exposed to hospitalized patients infected with SARS-CoV-2.
Describing hospital-acquired cases and SARS-CoV-2 infection transmission chains in healthcare settings is vitally essential to achieve control of this epidemic. To improve the quality of care and patient safety, this data must be accompanied by an analysis of the impact of infection control measures. In addition, an effective infection control program is urgently required to control the spread of the virus and protect both uninfected patients who require care for other medical or surgical conditions as well as health care professionals.
The main objective of this prospective, non-interventional - observational, hospital based study in adults and children is to describe and document suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective factors) at participating hospitals.
Characterization of the clinical features of the SARS-CoV-2 infection will help to identify potential sources of virus transmission as rapidly as possible and enable implementation of appropriate hygiene practices in hospitals.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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nosocomial infection/hospital acquired infection
When there is suspicion of a community-acquired case (admission of an infected patient) or nosocomial case (infection of a patient already hospitalized), a case report form including demographic data, medical history, and clinical and biological data on the infectious episode will be completed for each case, either patient, caregivers or health care professionals, presenting clinical signs or symptoms compatible with SARS-CoV-2 infection. The suspected cases will undergo nasopharyngeal swab collection and detection of SARS-CoV-2 in nasopharyngeal swabs will be done by real-time RT-PCR assay.
Hygiene measures applied by the service will be collected using a questionnaire as well as recommendations of the learned societies within the country regarding the risk of infection by coronavirus. In addition, data characterizing the service and hospital will also be collected (specialty, number of beds, number of nurses, doctors, etc.).
Eligibility Criteria
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Inclusion Criteria
2\) Suspect Case:
Fever above 37.8 ° C if no antipyretics are taken; And or Cough or pharyngeal pain or other symptom suggestive of respiratory infection. AND at least 1 of the following characteristics:
* return from a trip to China, or to a country in which the increase in the incidence of infections in SARS-CoV-2 has been proven;
* close contact (sharing the same place of family, professional life, same plane, etc.) with a person defined as a suspected or confirmed case;
* Occurring in an establishment having received at least one case of suspected or confirmed infection at SARS-CoV-2.
Or 3) Confirmed Case: The same clinical definitions, in addition to a positive RT-PCR-type virological diagnostic result specific to SARS-CoV-2
Exclusion Criteria
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Philippe VANHEMS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Service Hygiène, Epidémiologie et Prévention
Locations
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Service Hygiène, Epidémiologie et Prévention
Lyon, , France
Service Hygiène, Epidémiologie et Prévention
Lyon, , France
Countries
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References
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Saadatian-Elahi M, Picot V, Henaff L, Pradel FK, Escuret V, Dananche C, Elias C, Endtz HP, Vanhems P. Protocol for a prospective, observational, hospital-based multicentre study of nosocomial SARS-CoV-2 transmission: NOSO-COR Project. BMJ Open. 2020 Oct 22;10(10):e039088. doi: 10.1136/bmjopen-2020-039088.
Vanhems P. A breath of humanity in the era of Covid-19 vaccine. Vaccine. 2021 Jun 23;39(28):3649. doi: 10.1016/j.vaccine.2021.05.052. Epub 2021 May 24. No abstract available.
Other Identifiers
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69HCL20_0214
Identifier Type: -
Identifier Source: org_study_id
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