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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00797836
First received: November 24, 2008
Last updated: January 9, 2012
Last verified: November 2008
History of Changes
  Purpose

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)


Condition Intervention Phase
Tuberculosis
 Procedure: Quantiferon Gold
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cost-effectiveness of Quantiferon Gold in VITRO Test of T-lymphocytic Response for Detection of Latent Tuberculosis in At-risk Healthcare Workers

Resource links provided by NLM:

Drug Information available for: Interferon
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome 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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-effectiveness of replacing TST by QFTG [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 1024
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quantiferon Gold 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

Other Names:
  • Interferon-gama
  • evaluating tuberculosis-specific T-lymphocytic response

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797836

Locations
France
CHU Bichat Claude Bernard
Paris, Ile de France, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Guislaine CARCELAIN, Dr AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00797836     History of Changes
Other Study ID Numbers: P070312, STIC AOM04013
Study First Received: November 24, 2008
Last Updated: January 9, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Occupational Diseases
Tuberculosis
Tuberculin Test
Immunoassay

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
 Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2013