A Step Forward for Unraveling the Immune Mechanisms and Tools for Tuberculosis Spectrum Management | NCT07735754

NCT07735754

Overview

NCT ID: NCT07735754
Lead Sponsor: Irene Latorre RuedaOTHER
Official Title: A Step Forward for Unraveling the Immune Mechanisms and Tools for Tuberculosis Spectrum Management
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Sep 2026Estimated
Primary Completion Date: Sep 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 940Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Jose Dominguez, PhDContact
jadominguez@igtp.cat+34 935 54 30 50 ext. 6500

Similar Studies

Participant Group/Arms

Group 1: Active TB cases

Patients with bacteriologically confirmed pulmonary active TB diagnosed ≤14 days from the start of anti-TB treatment.

Group 2: Close contacts of active TB cases

Close contacts are defined as individuals sharing living spaces or spending at least 6 hours per day with index cases for at least more than 5 days per week. Both adult and pediatric cases with a positive immune test for TB infection (TST and/or IGRA) will be included, although IGRA will be performed at every visit if available. Only those contacts not currently receiving TB preventive treatment will be enrolled and monitored at the different timepoints.

Group 3: Controls with other respiratory diseases

Individuals with non-TB respiratory condition. Specifically, subjects with Acute Respiratory Infection (ARI), sarcoidosis or lung cancer; without any clinical picture compatible with the criteria defined in TB cases section.

Group 4: Healthy uninfected controls

Volunteers asymptomatic for active TB and for whom active disease has been excluded based on clinical examination and appropriate medical investigations, with no known prior exposure to a confirmed pulmonary TB case, and no immunological evidence of M. tuberculosis infection, proved with negative TST and/or IGRA result.