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

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ClinicalTrials.gov Identifier: NCT00797836
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : January 10, 2012
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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)

Condition or disease Intervention/treatment Phase
Tuberculosis Procedure: Quantiferon Gold Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1024 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
Drug Information available for: Interferon
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Cost-effectiveness of replacing TST by QFTG [ Time Frame: 18 months ]
  2. Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1) [ Time Frame: 18 months ]
  3. Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2) [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00797836     History of Changes
Other Study ID Numbers: P070312
STIC AOM04013 ( Other Identifier: French Ministry )
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: November 2008

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
Antiviral Agents
Anti-Infective Agents