NCT07608601

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,185

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jun 2026Aug 2026

First Submitted

Initial submission to the registry

May 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

29 days

First QC Date

May 20, 2026

Last Update Submit

May 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Percentage of positive QuantiFERON-TB Gold Plus

    At the inclusion

Secondary Outcomes (2)

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

    At the inclusion

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

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

Study Arms (2)

Hospital workers with direct patient contact

Diagnostic Test: QuantiFERON-TB Gold Plus

Hospital workers without direct patient contact

Diagnostic Test: QuantiFERON-TB Gold Plus

Interventions

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 with direct patient contactHospital workers without direct patient contact

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de NICE

Nice, Alpes Maritimes, 06000, France

Location

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 27, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

May 27, 2026

Record last verified: 2026-05

Locations