Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1024 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-11-30

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)

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Detailed Description

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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

Conditions

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Tuberculosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Quantiferon Gold

Group Type EXPERIMENTAL

Quantiferon Gold

Intervention Type PROCEDURE

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

Interventions

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Quantiferon 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

Intervention Type PROCEDURE

Other Intervention Names

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Interferon-gama evaluating tuberculosis-specific T-lymphocytic response

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)