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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07735754

Acronym

TB-SPECTRUM

Enrollment

940

Registered

2026-07-30

Start date

2026-09-01

Completion date

2029-12-01

Last updated

2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

Pulmonary tuberculosis, tuberculosis spectrum, close contacts, Active Case Finding, host-pathogen interactions, asymptomatic tuberculosis, incipient tuberculosis

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Contacts

CONTACTJose Dominguez, PhD

jadominguez@igtp.cat+34 935 54 30 50

CONTACTIrene Latorre, PhD

ilatorre@igtp.cat+34 935 54 30 50

Outcome results