Latent Tuberculosis Infection Screening Using QuantiFERON at Pre-Employment Assessment in Hospital Workers CHu Nice

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • QuantiFERON-TB Gold Plus

    Diagnostic test

    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.

Treatment groups

1,185 Participants
are divided into 2 treatment groups
Group A: Hospital workers with direct patient contact1 intervention
Group B: Hospital workers without direct patient contact1 intervention

Trial outcomes

Primary outcomes

1

Percentage of positive QuantiFERON-TB Gold Plus tests at pre-employment screening

Percentage of positive QuantiFERON-TB Gold Plus

Time frame
At the inclusion

Secondary outcomes

1

Association between risk factors and positive QuantiFERON-TB Gold Plus test

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

Time frame
At the inclusion
2

Percentage of workers with clinical follow-up after positive QuantiFERON-TB Gold Plus test

Chest X-ray, referral to the tuberculosis control center or specialist consultation, final diagnosis of latent tuberculosis infection and initiation of preventive treatment.

Time frame
From the positive QuantiFERON-TB Gold Plus test to completion of specialist follow-up.

Other outcomes

Sponsors and contacts

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