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Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tuberculosis

Intervention: Quantiferon Gold (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Guislaine CARCELAIN, Dr, Study Chair, Affiliation: Assistance Publique - Hôpitaux de Paris

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)

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: 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

Secondary outcome:

Cost-effectiveness of replacing TST by QFTG

Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1)

Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

CHU Bichat Claude Bernard, Paris, Ile de France 75018, France
Additional Information

Starting date: November 2008
Last updated: January 9, 2012

Page last updated: August 23, 2015

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