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NCT Number: NCT07608601

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: At the inclusion

    Percentage of positive QuantiFERON-TB Gold Plus

Secondary outcomes

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

    Time frame: 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

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hossam KILANI

CONTACT

[email protected]

06 73 17 92 83 ext. + 33

Jean-Yves MASSIMELLI

CONTACT

[email protected]

‭06 76 91 80 01‬

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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