- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07608601
Latent Tuberculosis Infection Screening Using QuantiFERON at Pre-Employment Assessment in Hospital Workers CHu Nice
20. maj 2026 opdateret af: Centre Hospitalier Universitaire de Nice
Relevance of Systematic Latent Tuberculosis Infection Screening Using QuantiFERON at Pre-Employment Assessment in Hospital Workers: A Retrospective Study at the University Hospital of Nice
This retrospective observational single-center study aims to evaluate the medical and occupational relevance of systematic screening for latent tuberculosis infection using QuantiFERON-TB Gold Plus during pre-employment occupational health assessment among hospital workers at the University Hospital of Nice.
Data will be collected retrospectively from occupational health medical records, immunology laboratory results and, when necessary, data from specialized follow-up by the tuberculosis control center.
The primary objective is to determine the proportion of positive QuantiFERON-TB Gold Plus tests at pre-employment screening.
Secondary objectives are to identify factors associated with a positive test, to describe the practical consequences of screening, including chest X-ray, diagnosis of latent tuberculosis infection and initiation of preventive treatment, and to estimate the cost of systematic screening.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
1185
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Hossam KILANI
- Telefonnummer: + 33 06 73 17 92 83
- E-mail: kilani.h@chu-nice.fr
Undersøgelse Kontakt Backup
- Navn: Jean-Yves MASSIMELLI
- Telefonnummer: 06 76 91 80 01
- E-mail: massimelli.jy@chu-nice.fr
Studiesteder
-
-
Alpes Maritimes
-
Nice, Alpes Maritimes, Frankrig, 06000
- CHU de Nice
-
Kontakt:
- Jean-Yves MASSIMELLI
- Telefonnummer: + 33 06 76 91 80 01
- E-mail: massimelli.jy@chu-nice.fr
-
Kontakt:
- Hossam KILANI
- Telefonnummer: +33 06 73 17 92 83
- E-mail: kilani.h@chu-nice.fr
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The study population consists of newly recruited hospital workers at the University Hospital of Nice who underwent pre-employment occupational health assessment and QuantiFERON-TB Gold Plus screening during the study period.
The population includes medical, paramedical, medico-technical, administrative, technical, logistical, transport and support staff, with or without direct patient contact.
Beskrivelse
Inclusion Criteria:
- Newly recruited hospital workers at the University Hospital of Nice.
- Workers who underwent pre-employment occupational health assessment during the study period.
- Workers who had a QuantiFERON-TB Gold Plus test performed as part of pre-employment screening.
Exclusion Criteria:
- Known history of active tuberculosis disease before employment.
- Previously known latent tuberculosis infection before employment.
- Incomplete or unusable occupational health records.
- Indeterminate QuantiFERON-TB Gold Plus results will be included in the descriptive analysis but excluded from comparative analyses of test positivity.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Hospital workers with direct patient contact
|
Retrospective analysis of QuantiFERON-TB Gold Plus results performed as part of routine pre-employment occupational health screening.
No additional diagnostic test or intervention will be performed for the purpose of the study.
|
|
Hospital workers without direct patient contact
|
Retrospective analysis of QuantiFERON-TB Gold Plus results performed as part of routine pre-employment occupational health screening.
No additional diagnostic test or intervention will be performed for the purpose of the study.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of positive QuantiFERON-TB Gold Plus tests at pre-employment screening
Tidsramme: At the inclusion
|
Percentage of positive QuantiFERON-TB Gold Plus
|
At the inclusion
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Association between risk factors and positive QuantiFERON-TB Gold Plus test
Tidsramme: At the inclusion
|
Variables collected included age, sex, country of birth, previous stay in a high tuberculosis-incidence area, prior contact with tuberculosis, immunosuppression status, occupational category, and direct patient contact
|
At the inclusion
|
|
Percentage of workers with clinical follow-up after positive QuantiFERON-TB Gold Plus test
Tidsramme: From the positive QuantiFERON-TB Gold Plus test to completion of specialist follow-up.
|
Chest X-ray, referral to the tuberculosis control center or specialist consultation, final diagnosis of latent tuberculosis infection and initiation of preventive treatment.
|
From the positive QuantiFERON-TB Gold Plus test to completion of specialist follow-up.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
30. juni 2026
Studieafslutning (Anslået)
30. august 2026
Datoer for studieregistrering
Først indsendt
20. maj 2026
Først indsendt, der opfyldte QC-kriterier
20. maj 2026
Først opslået (Faktiske)
27. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26SanteMentale01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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