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

NCT07735754 | Not Yet Recruiting

• 1 other identifier: 101236673
• Study Type: observational
• Target: 940
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

Study Arms (4)

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.

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited in 4 different hospitals located in Moldova (Chiril Draganiuc Institute, IPCD), Romania (Marius Nasta Institute, IPMN), Nigeria (Bingham University, BHU) and Spain (Serveis Clínics, SSCC).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, PBMCs, urine, mucosal lining fluid, strains, transbronchial biopsies, lung biopsies, bronchoalveolar lavage.

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jose Dominguez, PhD

CONTACT

+34 935 54 30 50; jadominguez@igtp.cat

Irene Latorre, PhD

CONTACT

+34 935 54 30 50; ilatorre@igtp.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07