Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis
Intervention: Quantiferon Gold (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s): Guislaine CARCELAIN, Dr, Study Chair, Affiliation: Assistance Publique - Hôpitaux de Paris
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)
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: 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
Secondary outcome: Cost-effectiveness of replacing TST by QFTGPrevalence and incidence of latent tuberculosis in exposed HCWs (Group 1) Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2)
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
CHU Bichat Claude Bernard, Paris, Ile de France 75018, France
Additional Information
Starting date: November 2008
Last updated: January 9, 2012
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