Clinical trial NCT00797836: Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers
Official title: Cost-effectiveness of Quantiferon Gold in VITRO Test of T-lymphocytic Response for Detection of Latent Tuberculosis in At-risk Healthcare Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tuberculosis
Keywords: Occupational Diseases
Tuberculosis
Tuberculin Test
Immunoassay
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 1024
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 18 months
Secondary outcomes:
measure: Cost-effectiveness of replacing TST by QFTG
timeFrame: 18 months
measure: Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1)
timeFrame: 18 months
measure: Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2)
timeFrame: 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Bichat Claude Bernard
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Guislaine CARCELAIN, Dr
role: STUDY_CHAIR
References:
citation: Lucet JC, Abiteboul D, Estellat C, Roy C, Chollet-Martin S, Tubach F, Carcelain G; QUANTIPS Study Group. Interferon-gamma release assay vs. tuberculin skin test for tuberculosis screening in exposed healthcare workers: a longitudinal multicenter comparative study. Infect Control Hosp Epidemiol. 2015 May;36(5):569-74. doi: 10.1017/ice.2015.19. Epub 2015 Feb 16.