Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers

Tuberculosis Clinical Trial

— QUANTIPS  

Official title:

Cost-effectiveness of Quantiferon Gold in VITRO Test of T-lymphocytic Response for Detection of Latent Tuberculosis in At-risk Healthcare Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797836
• Other study ID #: P070312
• Secondary ID: STIC AOM04013
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2008
• Last updated: January 9, 2012
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1024
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	CHU Bichat Claude Bernard	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cost-effectiveness of replacing TST by QFTG		18 months	No
Secondary	Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1)		18 months	No
Secondary	Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2)		18 months	No