Immunological Biomarkers in Tuberculosis Management

Study acronym: OPTI-4TB
StatusUnknown
PhaseNot applicable
Started

Record status This record was last updated August 12, 2024 (before its estimated September 10, 2026 completion). Its status may not reflect the trial's current state.

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Aug 2024); last known: Recruiting
  2. Primary completion date: Apr 9, 2023 to Sep 10, 2026
    • Study completion date: Apr 9, 2023 to Oct 10, 2026
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04271397
Lead Sponsor Hospices Civils de Lyon
Conditions
(from sponsor)		 Tuberculosis, Tuberculosis Infection
Related terms Latent Tuberculosis, Tuberculosis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov