INNOVA4TB: Innovation in Tuberculosis
Study Details
Study Description
Brief Summary
Tuberculosis (TB) is one of the major infectious diseases worldwide, and the emergence and spread of drug resistant cases is a public health threat. However, the conventional methods used for diagnosis and drug-susceptibility testing are not enough for controlling the disease. In addition, all TB patients, independently of their age, gender, severity of the disease and type of responsible strain, follow the same treatment duration (up to 20 months in drug resistant cases), which often leads to high frequency of adverse events, suboptimal adherence to treatment, and poor outcome. Therefore, a transition from programmatic to personalized management of TB is needed.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Diagnostic Test: 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. |
Diagnostic Test: 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. |
Diagnostic Test: 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 |
Diagnostic Test: 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 |
Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic
Evaluation and development of new technologies
|
Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy [01/01/2019 to 31/12/2022]
Sensitivity, Specificity and predictive values
Eligibility Criteria
Criteria
Inclusion Criteria:
- Immunosuppression will not be considered an exclusion criterion
Exclusion Criteria:
- Patients who are not able to give their informed consent to participate in the study will be excluded
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut D'Investigació Germans Trias I Pujol | Badalona | Barcelona | Spain | 08916 |
Sponsors and Collaborators
- Fundació Institut Germans Trias i Pujol
- Consorcio Centro de Investigación Biomédica en Red, M.P.
- Umeå University
- North-Western State Medical University named after I.I.Mechnikov
- INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC
- ODESA SIGNIFICANT DISEASES CENTER
- Vinnitsa National Medical University
- SERVICIOS CLINICOS SA
- Genome Identification Diagnostics GmbH
- EMPE DIAGNOSTICS AB
- MAGRITEK GMBH
- Universidad de La Frontera
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 823854