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)
The QUANTIPS study includes two components: 1. 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 2. 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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,024
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
CHU Bichat Claude Bernard
Paris, Île-de-France Region, France
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
Time frame: 18 months
Cost-effectiveness of replacing TST by QFTG
Time frame: 18 months
Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1)
Time frame: 18 months
Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2)
Time frame: 18 months
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