Quantiferon for Detection of Latent Tuberculosis in

Healthcare Workers
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...

Date First Received: November 24, 2008

Last Updated: May 22, 2009
Verified by: Assistance Publique - Hôpitaux de Paris, November 2008
Clinical Trial Phase: Phase 4 | Start Date: January 2009
Overall Status: Recruiting
Estimated Enrollment: 2600

Brief Summary
Official Title: “Cost-Effectiveness of Quantiferon Gold in Vitro Test of T-Lymphocytic
Response for Detection of Latent Tuberculosis in at-Risk Healthcare Workers”

Condition Keyword(s):
• Tuberculosis
Additional Keyword(s) Provided by Sponsor:
• Occupational Diseases
• Tuberculosis
• Tuberculin Test
• Immunoassay
Intervention(s):
• Procedure: Quantiferon Gold
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Condition MeSH Term(s), Assigned with an Experimental Algorithm:

• Tuberculosis
Intervention MeSH Term(s), Assigned with an Experimental Algorithm:
• Interferons

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)

Study Type: Interventional

Study Design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint

Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking:
Open Label, Primary Purpose: Diagnostic

Study Primary Completion Date: August 2010

Detailed Clinical Trial 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

Intervention(s) in this Clinical Trial

• Procedure: Quantiferon Gold

o 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Outcome Measures for this Clinical Trial

Primary Measures

• 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
o Time Frame: 18 months
Safety Issue?: No
Secondary Measures

• Cost-effectiveness of replacing TST by QFTG

o Time Frame: 18 months
Safety Issue?: No
• Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1)
o Time Frame: 18 months
Safety Issue?: No
• Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2)
o Time Frame: 18 months
Safety Issue?: No

Criteria for Participation in this Clinical Trial

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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)

EXCLUSION CRITERIA:

• No informed consent
• Age < 18 years
• Employment in this unit < one year

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Assistance Publique - Hôpitaux de Paris Other

Overall Clinical Trial Officials and Contacts

Guislaine CARCELAIN, Dr Study Chair AP-HP

Overall Contact: Jean-Christophe LUCET, MD, PhD +33 140 256 199 jean-
christophe.lucet@bch.aphp.fr

Additional Information
Information obtained from ClinicalTrials.gov on November 16, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00797836
Study ID Number: P070312
ClinicalTrials.gov Identifier: NCT00797836
Health Authority: France: Ministry of Health

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