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

Обзор

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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07735754 · 101236673

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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