Clinical Trial

A Step Forward for Unraveling the Immune Mechanisms and Tools for Tuberculosis Spectrum Management

Study acronym: TB-SPECTRUM
Not Yet Recruiting
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Summary
Tuberculosis (TB) is a significant infectious disease worldwide, with millions of people infected and major impact on mortality and public health. TB-SPECTRUM project will conduct a clinical study to characterize better clinically, microbiologically, and immunologically the spectrum of TB across the different stages of infection, including incipient and asymptomatic/subclinical TB, active disease, and post treatment phases. Passive and active case-finding (ACF) clinical approaches will be implemented, recruiting TB patients through public and private healthcare facilities and targeted community outreach, as well as their close contacts. This approach will allow the study of biomarker profiles associated with infection risk, disease progression and response to treatment. The specific objectives of the study will be: * To unravel immune mechanisms underlying the TB spectrum through a multidisciplinary approach. * To perform a clinical study (passive and ACF) for recruiting patients and their contacts for the enrolment of incipient/subclinical TB forms and the subsequent immune characterization and management. * To characterize host systemic and local immune responses on different TB immune states (with special focus on incipient, subclinical and cured TB) to better understand host-pathogen interactions and the established cellular/humoral immune mechanisms. * To stratify host immunity according to patient's clinical strain characterization and disease severity. * To develop and evaluate innovative tools for better management of all phases of the TB spectrum.
Trial Details
NCT Number NCT07735754
Lead Sponsor Irene Latorre Rueda
Collaborators: Leiden University Medical Center, Bingham University, University of Texas, Instituto de Investigação e Inovação em Saúde (i3S), Genome Identification Diagnostics GmbH, "Marius Nasta" Pulmonology Institute, INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC, SERVICIOS CLINICOS SA
Conditions Tuberculosis
Enrollment 940 participants
Start Date 2026-09
Primary Completion 2028-09 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-30