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

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis, Pulmonary

Age range

5 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 5 and 65 years
Willing and able to provide informed consent (or legal guardian consent) *GROUP 1: Active pulmonary TB*
Bacteriologically confirmed TB
Pulmonary TB
Anti-TB treatment ≤ 14 days *GROUP 2: Close contacts of active pulmonary TB*
Close contact with confirmed pulmonary TB case
Exposure ≥6 hours/day for ≥5 days/week
Positive TST and/or IGRA
NOT receiving TB preventive therapy *GROUP 3: Other respiratory diseases (non-TB)*
Diagnosis of ARI (Acute Respiratory Infection) and/or sarcoidosis and/or lung cancer
Clinical/radiological findings consistent with non-TB disease
NO clinical suspicion compatible with active TB *GROUP 4: Healthy uninfected controls*
No symptoms suggestive of active TB
Not known prior exposure to active TB
Negative TST and/or IGRA

Exclusion criteria

Known or suspected immunodeficiency (including HIV or immunosuppressive therapy)
Known or suspected pregnancy

Treatment and study plan

Primary outcomes

Characterization of the different TB-SPECTRUM stages (focusing on incipient and asymptomatic TB) assessed by clinical, immunological, microbiological and molecular assays.

Time frame: Close contacts (group 2) recruited in clinical sites (IPMN, IPCD, BHU and SSCC) and followed at baseline, 3 months and 12 months with clinical assessments and samplings. And symptoms will be monitored remotely by phone up to 24 months after enrollment.
Characterization of treatment monitoring and cured TB across the TB-SPECTRUM assesed by clinical, immunological, microbiological and molecular assays.

Time frame: Clinical assesments and sampling will be done in active TB cases (Group 1) at month 2, 6, and post-treatment (2-6 months after treatment).

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Latorre, PhD

CONTACT

[email protected]

+34 935 54 30 50 ext. 6500

Jose Dominguez, PhD

CONTACT

[email protected]

+34 935 54 30 50 ext. 6500

Sponsors and collaborators

Lead sponsor

Irene Latorre Rueda

Other

Collaborators

"Marius Nasta" Pulmonology Institute
Bingham University
Genome Identification Diagnostics GmbH
INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC
Instituto de Investigação e Inovação em Saúde (i3S)
Leiden University Medical Center
SERVICIOS CLINICOS SA
University of Texas

Registry information

Acronym: TB-SPECTRUM

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Jul 30, 2026
Registry last updated: Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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