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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Characterization of the different TB-SPECTRUM stages (focusing on incipient and asymptomatic TB) assessed by clinical, immunological, microbiological and molecular assays.
Characterization of treatment monitoring and cured TB across the TB-SPECTRUM assesed by clinical, immunological, microbiological and molecular assays.
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: