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Not yet recruiting NCT07735754

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

— Observational Tuberculosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Tuberculosis. Basic parameters: 5 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • 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).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07735754 · 101236673

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗