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

ConditionTuberculosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-65
SponsorIrene Latorre Rueda

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Known or suspected immunodeficiency (including HIV or immunosuppressive therapy)

Known or suspected pregnancy

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

940 Participants
are grouped into 4 trial groups
Group A: Group 1: Active TB cases
Group B: Group 2: Close contacts of active TB cases
Group C: Group 3: Controls with other respiratory diseases
Group D: Group 4: Healthy uninfected controls

Trial outcomes

Primary outcomes

1

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.
2

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).

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Irene Latorre Rueda

Lead sponsor

Fundació Institut Germans Trias i Pujol

Sponsor institution

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

This trial is not recruiting at the moment. You can still explore other options: