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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014