Innovation in Tuberculosis

Study Overview
=================
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.

Official Title
-----------------
Innovation in Tuberculosis

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active TB suspicion<br>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<br>* Evaluation and development of new technologies<br>|
| Latent TB infection<br>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<br>* Evaluation and development of new technologies<br>|
| NTM infection<br>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<br>* Evaluation and development of new technologies<br>|
| Uninfected control<br>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<br>* Evaluation and development of new technologies<br>|
| Other respiratory diseases<br>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<br>* Evaluation and development of new technologies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | Sensitivity, Specificity and predictive values | 01/01/2019 to 31/12/2022 |