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

Study Overview

• Status: Not yet recruiting
• Conditions: Latent Tuberculosis Infection
• Intervention / Treatment: Diagnostic test: QuantiFERON-TB Gold Plus

• Study Type: Observational
• Enrollment (Estimated): 1185

Contacts and Locations

• Study Contact: Name: Hossam KILANI; Phone Number: + 33 06 73 17 92 83; Email: kilani.h@chu-nice.fr
• Study Contact Backup: Name: Jean-Yves MASSIMELLI; Phone Number: ‭06 76 91 80 01‬; Email: massimelli.jy@chu-nice.fr

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06000
      • CHU de Nice
      • Contact: Jean-Yves MASSIMELLI; Phone Number: + 33 ‭06 76 91 80 01‬; Email: massimelli.jy@chu-nice.fr
      • Contact: Hossam KILANI; Phone Number: +33 06 73 17 92 83; Email: kilani.h@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hospital workers with direct patient contact	Diagnostic test: QuantiFERON-TB Gold Plus; 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	Diagnostic test: QuantiFERON-TB Gold Plus; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of positive QuantiFERON-TB Gold Plus tests at pre-employment screening	Percentage of positive QuantiFERON-TB Gold Plus	At the inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the inclusion
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.	From the positive QuantiFERON-TB Gold Plus test to completion of specialist follow-up.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Latent Infection; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: 26SanteMentale01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No