NCT00797836

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,024

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 10, 2012

Status Verified

November 1, 2008

Enrollment Period

1.9 years

First QC Date

November 24, 2008

Last Update Submit

January 9, 2012

Conditions

Tuberculosis

Keywords

Occupational DiseasesTuberculosisTuberculin TestImmunoassay

Outcome Measures

Primary Outcomes (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

    18 months

Secondary Outcomes (3)

  • Cost-effectiveness of replacing TST by QFTG

    18 months

  • Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1)

    18 months

  • Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2)

    18 months

Study Arms (1)

Quantiferon Gold

EXPERIMENTAL
Procedure: Quantiferon Gold

Interventions

Quantiferon GoldPROCEDURE

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

Also known as: Interferon-gama, evaluating tuberculosis-specific T-lymphocytic response
Quantiferon Gold

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bichat Claude Bernard

Paris, Île-de-France Region, 75018, France

Location

Related Publications (1)

  • Lucet JC, Abiteboul D, Estellat C, Roy C, Chollet-Martin S, Tubach F, Carcelain G; QUANTIPS Study Group. Interferon-gamma release assay vs. tuberculin skin test for tuberculosis screening in exposed healthcare workers: a longitudinal multicenter comparative study. Infect Control Hosp Epidemiol. 2015 May;36(5):569-74. doi: 10.1017/ice.2015.19. Epub 2015 Feb 16.

    PMID: 25682769DERIVED

MeSH Terms

Conditions

TuberculosisOccupational Diseases

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Guislaine CARCELAIN, Dr

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

November 1, 2008

Primary Completion

October 1, 2010

Study Completion

November 1, 2010

Last Updated

January 10, 2012

Record last verified: 2008-11

Locations

FR(1)