Innovation in Tuberculosis (INNOVA4TB)

Fundació Institut Germans Trias i Pujol

Status: Unknown

Conditions: Tuberculosis

Treatments: Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic

Study type: Observational

Funder types: Other

Identifiers

NCT04002869

823854

Details and patient eligibility

About

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.

Enrollment: 550 estimated patients

Sex: All

Ages: 1 month to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

550 participants in 5 patient groups

Active TB suspicion

Description:

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

Treatment:

Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic

Latent TB infection

Description:

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.

Treatment:

Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic

NTM infection

Description:

Adult and pediatric patients with lymphadenopathies caused by NTMs or individuals with chronic respiratory diseases with a NTM microbiologically confirmed by culture isolation.

Treatment:

Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic

Uninfected control

Description:

Both adult and children without active TB and no immunologic evidence of M. tuberculosis infection, with negative TST and/or IGRAs

Treatment:

Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic

Other respiratory diseases

Description:

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

Treatment:

Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic