Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
550 participants
OBSERVATIONAL
2019-01-01
2022-12-31
Brief Summary
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INNOVA4TB proposal will develop innovative technologies and approaches in order to improve the individual risk assessment for TB development, to rapidly diagnose active TB, to detect the drug susceptibility of the strain, to design tailor-made therapies, and to use biomarkers to guide and individualize the duration of antimicrobial therapy. This is of great importance for improving the quality of life of patients and ensuring treatment success, as well as for economic reasons for the healthcare system.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Active TB suspicion
This study will include both adults and children with suspicion of different degrees of severity of active TB (pulmonary and extrapulmonary) to bring the investigator's study population into line with the routine clinical practice and to avoid the spectrum bias
Immunologic, molecular, metabolomic and radiolologic diagnostic
Evaluation and development of new technologies
Latent TB infection
Individuals with latent TB infection (adults and children), with positive TST and/or IGRAs; without any sign or radiological evidence of TB disease or any clinical picture compatible with the criteria defined in the section TB cases.
Immunologic, molecular, metabolomic and radiolologic diagnostic
Evaluation and development of new technologies
NTM infection
Adult and pediatric patients with lymphadenopathies caused by NTMs or individuals with chronic respiratory diseases with a NTM microbiologically confirmed by culture isolation.
Immunologic, molecular, metabolomic and radiolologic diagnostic
Evaluation and development of new technologies
Uninfected control
Both adult and children without active TB and no immunologic evidence of M. tuberculosis infection, with negative TST and/or IGRAs
Immunologic, molecular, metabolomic and radiolologic diagnostic
Evaluation and development of new technologies
Other respiratory diseases
Subjects with ARIs, and subjects with lung cancer; without any clinical picture compatible with the criteria defined in TB cases section. Patients with ARIs will be identified as individuals with clinical signs, symptoms and radiology of respiratory infections, and microbiological confirmation of non-TB origin. Patients with lung cancer will be identified as those with a high clinical suspicion, a suggestive chest X-ray/computed tomography scan, and a confirmed histopathological/cytological diagnosis
Immunologic, molecular, metabolomic and radiolologic diagnostic
Evaluation and development of new technologies
Interventions
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Immunologic, molecular, metabolomic and radiolologic diagnostic
Evaluation and development of new technologies
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Month
99 Years
ALL
Yes
Sponsors
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Consorcio Centro de Investigación Biomédica en Red (CIBER)
OTHER_GOV
Umeå University
OTHER
North-Western State Medical University named after I.I.Mechnikov
OTHER
INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC
UNKNOWN
ODESA SIGNIFICANT DISEASES CENTER
UNKNOWN
Vinnitsa National Medical University
OTHER
SERVICIOS CLINICOS SA
UNKNOWN
Genome Identification Diagnostics GmbH
UNKNOWN
EMPE DIAGNOSTICS AB
UNKNOWN
MAGRITEK GMBH
UNKNOWN
Universidad de La Frontera
OTHER
Fundació Institut Germans Trias i Pujol
OTHER
Responsible Party
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Jose Antonio Dominguez Benitez
Senior Researcher
Locations
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Institut D'Investigació Germans Trias I Pujol
Badalona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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823854
Identifier Type: -
Identifier Source: org_study_id
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