Innovation in Tuberculosis
- Conditions
- Tuberculosis
- Interventions
- Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic
- Registration Number
- NCT04002869
- Lead Sponsor
- Fundació Institut Germans Trias i Pujol
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 550
- Immunosuppression will not be considered an exclusion criterion
- Patients who are not able to give their informed consent to participate in the study will be excluded
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Uninfected control Immunologic, molecular, metabolomic and radiolologic diagnostic Both adult and children without active TB and no immunologic evidence of M. tuberculosis infection, with negative TST and/or IGRAs Latent TB infection Immunologic, molecular, metabolomic and radiolologic diagnostic 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. Other respiratory diseases Immunologic, molecular, metabolomic and radiolologic diagnostic 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 Active TB suspicion Immunologic, molecular, metabolomic and radiolologic diagnostic 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 NTM infection Immunologic, molecular, metabolomic and radiolologic diagnostic Adult and pediatric patients with lymphadenopathies caused by NTMs or individuals with chronic respiratory diseases with a NTM microbiologically confirmed by culture isolation.
- Primary Outcome Measures
Name Time Method Diagnostic accuracy 01/01/2019 to 31/12/2022 Sensitivity, Specificity and predictive values
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institut D'Investigació Germans Trias I Pujol
🇪🇸Badalona, Barcelona, Spain