Latent Tuberculosis InfectionNCT07608601
Latent Tuberculosis Infection Screening Using QuantiFERON at Pre-Employment Assessment in Hospital Workers CHu Nice
An observational study of Latent Tuberculosis Infection, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis Infection
- What is being tested?
- QuantiFERON-TB Gold Plus
- How many people
- 1,185 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Latent Tuberculosis Infection
- Being tested
- QuantiFERON-TB Gold Plus
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuantiFERON-TB Gold PlusDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Hospital workers with direct patient contact | Not described Receives: Diagnostic Test: QuantiFERON-TB Gold Plus | |
| Hospital workers without direct patient contact | Not described Receives: Diagnostic Test: QuantiFERON-TB Gold Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of positive QuantiFERON-TB Gold Plus tests at pre-employment screening
Percentage of positive QuantiFERON-TB Gold Plus
Measured: At the inclusion
Secondary outcomes (2)
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
Measured: 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.
Measured: From the positive QuantiFERON-TB Gold Plus test to completion of specialist follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Apr 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Tuberculosis InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608601
- Sponsor's protocol ID
- 26SanteMentale01
- Status last verified
- Sep 2026
- First submitted
- 20 May 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07608601
- Acronym / sponsor ID
- 26SanteMentale01
- Conditions
- Latent Tuberculosis Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,185 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital workers with direct patient contact | – | Diagnostic Test: QuantiFERON-TB Gold Plus |
| Hospital workers without direct patient contact | – | Diagnostic Test: QuantiFERON-TB Gold Plus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuantiFERON-TB Gold PlusRetrospective 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. | Diagnostic test | Hospital workers with direct patient contact, Hospital workers without direct patient contact |
Primary outcome
Percentage of positive QuantiFERON-TB Gold Plus tests at pre-employment screening
Time frame: At the inclusion
Percentage of positive QuantiFERON-TB Gold Plus
2 secondary outcomes
Association between risk factors and positive QuantiFERON-TB Gold Plus test
Time frame: At the inclusion
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Latent Tuberculosis Infection, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of positive QuantiFERON-TB Gold Plus tests at pre-employment screening (time frame: At the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.