Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers (QUANTIPS)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 4

Conditions

Tuberculosis

Treatments

Procedure: Quantiferon Gold

Study type

Interventional

Funder types

Other

Identifiers

NCT00797836

STIC AOM04013 (Other Identifier)

P070312

Details and patient eligibility

About

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)

Full description

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

Enrollment

1,024 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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