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European-Latin American TB Research Collaboration Network

Periodic Reporting for period 1 - EUSAT-RCS (European-Latin American TB Research Collaboration Network)

Reporting period: 2019-04-01 to 2021-09-30

In 2016, the World Health Assembly launched the WHO’s ‘End TB strategy’; an ambitious project to reduce TB incidence by 90% before 2035 and progress to 1 TB case per million in 2050 worldwide. Effective routes to TB
elimination are, among others, optimized treatment regimens to shorten treatment duration and better diagnostic methods.
Unfortunately, advances are very slow due to a huge lack of funding and clinical research capacity to conduct trials. The TB research community needs to be both creative and innovative to build and strengthen existing capacity as well as to expand clinical trial networks to perform more cost- and time effective drug- and diagnostic trials.
In our consortium we aim to strenghten the European-Latin American TB Research Collaboration Network (EUSAT-RCS), offer capacity building for Paraguayan and European TB professionals and build up a Latin American
TB clinical hub. A group of early stage researchers, Experienced researchers, technicians and other professionals are brought together to carry out clinical research spanning epidemiology of TB in vulnerable populations to genome wide association studyies and the validation of an innovative Electronic Nose device for point-of-care diagnostic value.

Our consortium work has three research specific objectives:
1. to investigate little explored aspects of TB drug treatment
2. to validate a portable, battery loaded Electronic Nose (eNose) device; a novel and very promising 'point of care' diagnostic method for TB
3. evaluate an eNose device as a biomarker of response to treatment.
Work performed and main results achieved so far (Period april 2019-september 2021):
1. management and communication-dissimination plan designed
2. logistics executive board meetings implemented
3. secondment gantt chart designed
4. secondments logistics and individual payments arranged

5. Dedicated mentoring event: Set up structure for guidance young EUSAT-RCS consortium members by PANACEA consortium members. First annual meeting Panacea to attend was in March 2020 and coincided with the planned start of PriNose study. Since that date, other live PANACEA events haven't taken place yet due to COVID.

6. Systematic review high dose rifampicin, manuscript in final stage of preparation. document uploaded in theEU portal
7. Systematic review screening for tuberculosis in prisons, manuscript in preparation.
8. Pharmacokinetics and dynamics of adult paraguayan tuberculosis patients, manuscript in final stage of preparation

9. Pharmacokinetics workshop (UMCGroningen) prepared as pre-congress activity (Union World Congress of tuberculosis, october 2020): suspended due to COVID.
Planned to provide the course online this year.

10. Protocol RIAlta, ethics approval pending, registration in clinical trial agreements in final stage, responsabilities pharmacy delegated to different trial sites. Paraguayan pharmacist training planned in secondment whenever travel is possible after COVID. Trial starts in first trial site in Europe: planned december 2021.
11. Protocol PriNose, ethics approval obtained, registration in Trial started on 13-10-2021.
The secondments performed until now were considered very usefull. 4 PhD candidates are currently involved in this project: 1 from Spain, 1 from Portugal and 2 from Paraguay. Three of the PhD trajectories will be about the studies performed in this project and hopefully will all come to an end maximum 1-2 years after finishing the project.
With these young professionals we have a dedicated group of professionals with excellent networks in South America and Europe to continue to perform research independently in the coming years. At the end of the project these young PhD candidates will also be involved in the writing of a new grant proposal to learn about grant writing. They will also obtain the skills to guide a group of new researchers while performing their multi-center studies.

The involvement of professionals from the Paraguayan hospital in the secondments has paved the way to more scientific activities

The ethics committee of Paraguay had the chance to learn from the collaegues in Spain. Due to COVID they had to stay inside the home which actually forced them even more to focus on the purpose of their travel and they have made very good progress in evaluating research proposals. This was a real game changer in the Paraguayan ethics committee. Another secondment to Spain will be made to the ethics committee to broaden n this positive experience to more people involved in ethics from Paraguay.

The systematic review, that is about to be submitted to a journal soon, has provided the evidence and assurance that high dose rifampicin is safe and also seems more effective to treat TB patients. This publication will help ethics committees who might be reluctant to use high dose rifampicin.
The dose of rifampicin we are going to use in the RIAlta study will provide us with answers of the safety of high dose rifampicin in more vulnerable patients (patients in coma, with liver or renal failure etc). The evidence we gather in the RIAlta study will have high impact to the whole TB research society which is actually planning phase III trials. If we can safely use the high dose rifampicin in all patients we will leave no one behind; we might include all TB patients in these trials! The RIAlta study will start soon from now.

The PriNose study that has started recently has learned us that Paraguay is open to perform clinical trials and that they are able to perform large studies with the collaboration of many professionals and different ministeries involved. This study directly influences the lives of of a marginalised group suffering a lot from TB, even more so after the COVID pandemia in which only very few TB cases were captured from the Paraguayan prisons.
when the electronic nose device actually performs well it may have a hughe impact on the TB screening activities in vulnerable groups (prisoners, indigenous people): it will become easy to rule out TB in a person. If TB is not ruled out more expensive diagnostics will be used to confirm the diagnosis. In this way screening for TB will be more cost effective and for that reason much more feasible than nowadays which makes it a reachable goal for the near future performing screening for TB in vulnerable populations.
The systematic review about screening for TB in prisons learned us that there is not much evidence published about this issue. For that reason we have done a retrospective cohort study with data from the National TB program to learn about the robustness of TB diagnosis in prisons in Paraguay. We have found out that most of the TB diagnosed is robust and that it exists of >95% of pulmonary TB cases which are confirmed bacteriologically. They also finish their treatments in a high rate in Paraguay. What we probably miss in Paraguay with their actual screening methods are extrapulmonary cases as pleural TB, lymphnode TB and other localisations of TB. While we now increase the technology to diagnose TB in prisons we hypotheze that we might find a lot more cases in early stages.
logo EUSAT-RCS consortium
Launch Prinose study Paraguay
Launch PriNose study Paraguay
meeting with minister of justice Paraguay
Launch Prinose study Paraguay
launch Prinose study Paraguay