Immunological Biomarkers in Tuberculosis Management
OPTI-4TB
Optimization of Tuberculosis Diagnosis and Management Using Four Immunological Biomarkers
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
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
September 30, 2019
CompletedFirst Submitted
Initial submission to the registry
December 23, 2019
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 10, 2026
August 12, 2024
August 1, 2024
7 years
December 23, 2019
August 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Concordance of the kinetics of biomarkers with the evolution of the disease
It is a composite outcome. Evolution of the disease is defined by clinical status, radiological computed tomography evolution and negation of the mycobacterial culture of routine respiratory samples. The biomarkers assessed are: 1\) a combination of IGRAs test (QuantiFERON-Gold Plus and HBHA); 2) a transcriptomic signature; 3) a protein signature; 4) a phenotypic signature (by implementing an immunomonitoring approach).
6 months
Secondary Outcomes (6)
Analytical characteristics of a combination of 2 IGRAs (QuantiFERON-TB Gold Plus (QFT-P) and HBHA) in the diagnosis / prognosis of tuberculosis disease.
6 months
Performance of an immunomonitoring test by mass or flow cytometry in the diagnosis / prognosis of tuberculosis by measuring the dynamics of the blood population of T lymphocytes over time.
6 months
Evaluate the performance of a test based on the interpretation of a transcriptomic signature in plasma in the diagnosis / prognosis of TB.
6 months
Assess the performance of a test based on the interpretation of a protein signature in the diagnosis / prognosis of tuberculosis.
6 months
Determine the achievement of target concentrations of rifampicin
6 months
- +1 more secondary outcomes
Study Arms (2)
Active tuberculosis
OTHERLatent tuberculosis infection
OTHERInterventions
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.
Patients with Latent tuberculosis infection will have a single specific sample of 14 mL.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service des Maladies Infectieuses - Hôpital de la Croix Rousse - Hospices Civils de Lyon
Lyon, 69004, France
Related Publications (1)
Bahuaud O, Genestet C, Hoffmann J, Dumitrescu O, Ader F. Opti-4TB: A protocol for a prospective cohort study evaluating the performance of new biomarkers for active tuberculosis outcome prediction. Front Med (Lausanne). 2022 Sep 14;9:998972. doi: 10.3389/fmed.2022.998972. eCollection 2022.
PMID: 36186786DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2019
First Posted
February 17, 2020
Study Start
September 30, 2019
Primary Completion (Estimated)
September 10, 2026
Study Completion (Estimated)
October 10, 2026
Last Updated
August 12, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share