Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers

Study Overview
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Brief Summary
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The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in countries with a high proportion of population having received vaccination with the BCG. We aim to determine the cost-effectiveness of Quantiferon gold (QTFG), compared to BCG vaccine to detect latent tuberculosis in exposed healthcare workers (HCWs)

Detailed Description
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The QUANTIPS study includes two components: survey of HCWs working in high-risk units (respiratory diseases or infectious diseases with at least 5 case of smear-positive pulmonary tuberculosis par year) from 14 University hospitals in France Follow-up of HCWs with unexpected exposure to a patient with contagious tuberculosis (delay in respiratory isolation of a smear-positive patient) in 4 University hospitals Main objective: Therapeutic impact of tuberculosis screening using TST compared to QFTG. The impact is defined by the decision to treat of not a HCW with latent tuberculosis using QFTG, compared to the decision which would have been based on TST alone Secondary objectives: Cost-effectiveness of replacing TST by QFTG Prevalence and incidence of latent tuberculosis in exposed HCWs (Part 1) Incidence of latent tuberculosis in HCWs exposed to an index case (part 2) Inclusion: HCWs who volunteer to participate in units with at least 5 patients with smear-positive tuberculosis each year (Group 1), HCWs exposed to a smear-positive patient non isolated at hospital admission (Group 2) Study population: 2000 (Group 1) and 600 (Group 2) HCWs Study duration: inclusion during 3 months, follow-up of one year (Group 1 ); Inclusion for one year, with a 3-month follow up (Group 2) Study exams: Group 1 : TST, QFTG, chest radiography at baseline and after one year Group 2 : TST, QFTG, chest radiography at baseline (within 3 weeks after exposure) and after 3 months Endpoints: therapeutic decision regarding tuberculosis treatment, with a cost-effectiveness analysis (Markov's modelling) prevalence and incidence of latent tuberculosis

Official Title
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Cost-effectiveness of Quantiferon Gold in VITRO Test of T-lymphocytic Response for Detection of Latent Tuberculosis in At-risk Healthcare Workers

Conditions
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Tuberculosis

Intervention / Treatment
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* Procedure: Quantiferon Gold


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Group 1: Healthcare worker volunteering for the study Stable (expected employment in the unit > one year) Working in a high-risk units for tuberculosis (at least 5 cases of smear-positive pulmonary tuberculosis per year) Group 2 : Healthcare worker volunteering for the study With an unexpected exposure to a patient with contagious tuberculosis (delay in respiratory isolation of a smear-positive patient) EXCLUSION CRITERIA: No informed consent Age < 18 years Employment in this unit < one year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quantiferon Gold<br> | Procedure: Quantiferon Gold<br>* Interferon-gama release assay evaluating tuberculosis-specific T-lymphocytic response Health Personnel Hospitals, General Occupational Diseases/*epidemiology/*statistics & numerical data Occupational Exposure/*statistics & numerical data Tuberculosis/*diagnosis/*epidemiology/prevention & control Immunologic Tests/methods/*standards Disease Transmission, Horizontal/*statistics & numerical data Patient Isolation Tuberculin Test/standards/*methods Immunoassay/methods/*standards T-Lymphocytes/immunology Interferon Type II/*blood/*analysis *Reagent Kits, Diagnostic Mass Screening/*methods Incidence Follow-Up Studies Comparative Study Sensitivity and Specificity Risk Assessment/*methods<br>* Other names: evaluating tuberculosis-specific T-lymphocytic response;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic impact of tuberculosis screening using QFTG compared to TST. The impact is defined by the decision to treat of not a HCW with latent tuberculosis using QFTG, compared to the decision which would have been based on TST alone |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of replacing TST by QFTG |  | 18 months | 
| Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1) |  | 18 months | 
| Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2) |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occupational Diseases, Tuberculosis, Tuberculin Test, Immunoassay