[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649659":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":21,"locations":10,"responsibleParty":31,"collaborators":35,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":80,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":10},{"fullName":5,"class":6},"Fundació Institut Germans Trias i Pujol","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Group 1: Active TB cases",null,"Patients with bacteriologically confirmed pulmonary active TB diagnosed ≤14 days from the start of anti-TB treatment.",{"label":13,"type":10,"description":14,"interventionNames":10},"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\u002For 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.",{"label":16,"type":10,"description":17,"interventionNames":10},"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.",{"label":19,"type":10,"description":20,"interventionNames":10},"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\u002For IGRA result.",[22,28],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Jose Dominguez, PhD","CONTACT","+34 935 54 30 50","6500","jadominguez@igtp.cat",{"name":29,"role":24,"phone":25,"phoneExt":26,"email":30},"Irene Latorre, PhD","ilatorre@igtp.cat",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Irene Latorre Rueda","Senior Researcher",[36,38,41,43,45,47,49,51],{"name":37,"class":6},"Leiden University Medical Center",{"name":39,"class":40},"Bingham University","UNKNOWN",{"name":42,"class":6},"University of Texas",{"name":44,"class":40},"Instituto de Investigação e Inovação em Saúde (i3S)",{"name":46,"class":40},"Genome Identification Diagnostics GmbH",{"name":48,"class":6},"\"Marius Nasta\" Pulmonology Institute",{"name":50,"class":40},"INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC",{"name":52,"class":40},"SERVICIOS CLINICOS SA","100649659","a-step-forward-for-unraveling-the-immune-mechanisms-and-tools-for-tuberculosis-spectrum-management-100649659",false,"NCT07735754","A Step Forward for Unraveling the Immune Mechanisms and Tools for Tuberculosis Spectrum Management","TB-SPECTRUM","Inclusion Criteria:\n\n* Age between 5 and 65 years\n* Willing and able to provide informed consent (or legal guardian consent) \\*GROUP 1: Active pulmonary TB\\*\n* Bacteriologically confirmed TB\n* Pulmonary TB\n* Anti-TB treatment ≤ 14 days \\*GROUP 2: Close contacts of active pulmonary TB\\*\n* Close contact with confirmed pulmonary TB case\n* Exposure ≥6 hours\u002Fday for ≥5 days\u002Fweek\n* Positive TST and\u002For IGRA\n* NOT receiving TB preventive therapy \\*GROUP 3: Other respiratory diseases (non-TB)\\*\n* Diagnosis of ARI (Acute Respiratory Infection) and\u002For sarcoidosis and\u002For lung cancer\n* Clinical\u002Fradiological findings consistent with non-TB disease\n* NO clinical suspicion compatible with active TB \\*GROUP 4: Healthy uninfected controls\\*\n* No symptoms suggestive of active TB\n* Not known prior exposure to active TB\n* Negative TST and\u002For IGRA\n\nExclusion Criteria:\n\n* Known or suspected immunodeficiency (including HIV or immunosuppressive therapy)\n* Known or suspected pregnancy",true,"ALL","5 Years","65 Years",{"count":65,"type":66},940,"ESTIMATED","2 Years","OBSERVATIONAL","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\u002Fsubclinical 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:\n\n* To unravel immune mechanisms underlying the TB spectrum through a multidisciplinary approach.\n* To perform a clinical study (passive and ACF) for recruiting patients and their contacts for the enrolment of incipient\u002Fsubclinical TB forms and the subsequent immune characterization and management.\n* 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\u002Fhumoral immune mechanisms.\n* To stratify host immunity according to patient's clinical strain characterization and disease severity.\n* To develop and evaluate innovative tools for better management of all phases of the TB spectrum.",[71],"Tuberculosis",[73,74,75,76,77,78,79],"Pulmonary tuberculosis","tuberculosis spectrum","close contacts","Active Case Finding","host-pathogen interactions","asymptomatic tuberculosis","incipient tuberculosis","NOT_YET_RECRUITING","2026-07-24",{"date":83,"type":84},"2026-07-30","ACTUAL",{"date":86,"type":66},"2026-09",{"date":88,"type":66},"2029-12",{"name":33,"class":6}]