Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers

Status Completed

Clinical Trial 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 Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00797836
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase	Phase 4
Start date	November 2008
Completion date	November 2010

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05738681` - Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial	Phase 2/Phase 3
Recruiting	`NCT05526885` - Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa	N/A
Completed	`NCT04369326` - Community Initiated Preventive Therapy for TB	N/A
Recruiting	`NCT04568967` - TB-CAPT EXULTANT - HIV	N/A
Completed	`NCT02337270` - Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol	Phase 1
Not yet recruiting	`NCT06253715` - Shortened Regimen for Drug-susceptible TB in Children	Phase 3
Recruiting	`NCT04271397` - Immunological Biomarkers in Tuberculosis Management	N/A
Withdrawn	`NCT03639038` - Tuberculosis Diagnosis by Flow Cytometry
Completed	`NCT03199313` - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid	Phase 1
Recruiting	`NCT04975178` - Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa	Phase 3
Completed	`NCT04463680` - Rifampin and the Contraceptive Implant	Phase 4
Completed	`NCT03973970` - Assessing the Ability of the T-SPOT®.TB Test (IQ)
Recruiting	`NCT04230395` - Alcohol Reduction Among People With TB and HIV in India	N/A
Completed	`NCT04874948` - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment	Phase 1
Active, not recruiting	`NCT02906007` - Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV	Phase 1/Phase 2
Not yet recruiting	`NCT05917210` - Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda	N/A
Not yet recruiting	`NCT05845112` - Start Taking Action For TB Diagnosis
Not yet recruiting	`NCT06017843` - Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding	N/A
Active, not recruiting	`NCT02715271` - Study of TB Lesions Obtained in Therapeutical Surgery
Completed	`NCT02781909` - Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers — QUANTIPS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms