Immunological Biomarkers in Tuberculosis Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2026-10-10

Brief Summary

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Tuberculosis (TB) is the leading cause of death by infectious disease in the world, responsible for 1.6 million deaths in 2017. The treatment of active TB requires at least a 6-month combined antibiotic regimen and can cause heavy side effects. As a consequence, treatment adherence is not optimal, particularly in primary care settings. Rapid and reliable monitoring of anti-TB treatment adherence and efficacy is critical to provide adequate patient care and curb relapse episodes and acquired drug resistance.

Investigators propose to evaluate the performance in terms of diagnosis accuracy and outcome prediction of four new biomarkers of active TB: 1) a double IGRA (Interferon Gamma Release Assay) including QuantiFERON-Gold Plus® and HBHA; 2) a whole blood transcriptomic analysis of mRNA (messenger Ribonucleic acid) expression of a panel of 150 genes; 3) a whole blood proteomic analysis; 4) an ex vivo immunophenotyping using flow and mass cytometry to characterize the lymphocyte populations.

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Detailed Description

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Conditions

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Tuberculosis Tuberculosis Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Active tuberculosis

Group Type OTHER

Multiple blood samples

Intervention Type OTHER

Patients with active tuberculosis will have 5 research-specific blood samples: V1, (baseline) immediately before initiating anti-tuberculosis treatment, then 4 samples during anti-tuberculosis treatment and follow-up, i.e. at 48 hours (V2), 15 days (V3), 2 months (V4) and 6 months (V5) after initiation of treatment. The total volume of each sample will be 20 mL for a total of 100 mL.

Latent tuberculosis infection

Group Type OTHER

Single blood sample

Intervention Type OTHER

Patients with Latent tuberculosis infection will have a single specific sample of 14 mL.

Interventions

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Multiple blood samples

Patients with active tuberculosis will have 5 research-specific blood samples: V1, (baseline) immediately before initiating anti-tuberculosis treatment, then 4 samples during anti-tuberculosis treatment and follow-up, i.e. at 48 hours (V2), 15 days (V3), 2 months (V4) and 6 months (V5) after initiation of treatment. The total volume of each sample will be 20 mL for a total of 100 mL.

Intervention Type OTHER

Single blood sample

Patients with Latent tuberculosis infection will have a single specific sample of 14 mL.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Adult ≥ 18 year-old

* Patients having given written consent
* Patients accepting a follow up ≥ 6 months
* Proven active tuberculosis (positive direct examination and/or PCR)
* Latent tuberculosis infection assessed by positive IGRA

Exclusion Criteria

* Malignant solid tumor
* Malignant hemopathy
* Solid organ transplantation or hematopoietic stem cell transplantation
* Immunosuppressive treatments (i.e. biologics, calcineurin inhibitors, corticosteroids)
* Auto-inflammatory disease
* Chronic liver diseases
* Chronic infection with HIV, HCV (hepatitis C virus) or HBV (hepatitis B virus)
* Antimycobacterial treatment initiated \> 7 days
* Pregnancy or breastfeeding
* Refusal to participate to the study
* Persons deprived of their liberty by judicial or administrative decision
* Protected adults
* Patients not affiliated to health-care social security
* The homeless

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No