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Innovation in Tuberculosis

Periodic Reporting for period 1 - INNOVA4TB (Innovation in Tuberculosis)

Reporting period: 2019-01-01 to 2020-12-31

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. A transition from programmatic to personalized management of TB is needed.

Our 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.

The overall objective of INNOVA4TB is to enhance and strengthen the collaborative research among sectors and to form a network aimed to perform high-quality and translational research in the field of diagnosis and management of TB. The consortium is constituted by 16 institutions from 8 countries that combine complementary and synergic expertise: clinical management (hospitals), basic science and new technologies (academic institutions), and industrial development and entrepreneurship culture (SMEs). The exchanges between the institutions allow the participants to progress in their career perspectives.
During the first period of the project we prepared the protocols to carry out different studies, obtained authorizations from Ethics Committees, and initiated sample collection.

In order to rapidly diagnose active TB and to detect the drug susceptibility of the strain, we initiated the evaluations of different technologies: rapid detection of M. tuberculosis antigen in urine, characterization of a specific profile of urinary metabolome, development of a new device for stimulating the growth of the mycobacteria during the transport, validation of a new molecular method for detecting drug resistance, and evaluation of different molecular technologies for detecting drug resistance against the anti-TB drugs. In addition, we are elaborating a consensus document for interpreting the results of the most used molecular test (GeneXpert Ultra), and we published the results of the study of the detection of M. tuberculosis in oral mucosa (doi: 10.3390/jcm9124124).

Regarding the new strategies for improving anti-TB therapy, we isolated compounds produced by bacteria from the Black Sea and tested their anti-TB activity, evaluated the activity of Gallium against M. tuberculosis in an in-vitro model, and developed nanoparticles with new compounds to test their anti-TB activity.

Finally, we published an Editorial in a scientific journal about the terrible impact of COVID-19 in the health systems in general, but also in tuberculosis control.
Despite the difficulties faced during the last year as a consequence of the COVID-19 pandemic the activities performed in the frame of the consortium have had relevant impact.

A total of 27 INNOVA4TB participants have performed secondments, and this participation was pretty gender-balanced (16 women and 11 men). Thanks to the secondments, the participants have increased their professional potentiality and developed new skills, working in facilities and scientific-technical platforms that are not available in their home centres of origin or in institutions where the incidence of tuberculosis is around 10 times higher than in their countries of origin. In many cases they faced new professional situations, improving their language skills and empowering themselves to take on more ambitious professional challenges.

The consortium has launched 25 studies where academic and non-academic partners collaborate, contributing with different points of view and capacities to achieve results. All these projects, which are still in very early stages, are undoubtedly of great scientific importance, and will have a great impact once we have definitive results.

The project aims to generate new technologies that allow progress in the management of patients with tuberculosis. The companies in the consortium are participanting in the development of different technologies, of molecular and immunological basis, for the diagnosis of patients with tuberculosis and also with non-tuberculous mycobacterial infections. This type of activity will generate for these European companies the possibility of generating new techniques that they will be able to introduce in the market, with the consequent innovative benefit at European level driven economic and welfare.

Finally, we believe that the project can have an impact on European policies. On one hand, there is an impact at the local level in those countries where there is a high incidence of tuberculosis (Ukraine and Moldova). Consensus documents are in elaboration regarding the utility and implication of molecular methods in the clinical management of MDR-TB patients. On the other hand, it is interesting to note the great similarities between tuberculosis and COVID-19. Both are respiratory infections, which are transmitted through the air and cause high mortality. At the moment there is a great awareness of the importance of research and science, but also of the impact it has on the health of the population, but on the economy of the countries. There is an opportunity to influence at the political level in promoting policies to control tuberculosis.