Tuberculosis
Conditions
Keywords
Occupational Diseases, Tuberculosis, Tuberculin Test, Immunoassay
Brief summary
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
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
Interventions
PROCEDUREQuantiferon Gold
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
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1) | 18 months |
| Cost-effectiveness of replacing TST by QFTG | 18 months |
| Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2) | 18 months |
Countries
France
Outcome results
None listed