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

NCT07735754 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 940

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Bingham University

    collaborator UNKNOWN

  • University of Texas

    collaborator OTHER

  • Instituto de Investigação e Inovação em Saúde (i3S)

    collaborator UNKNOWN

  • Genome Identification Diagnostics GmbH

    collaborator UNKNOWN

  • "Marius Nasta" Pulmonology Institute

    collaborator OTHER

  • INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC

    collaborator UNKNOWN

  • SERVICIOS CLINICOS SA

    collaborator UNKNOWN

  • Irene Latorre Rueda

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2029-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735754 on ClinicalTrials.gov