The World Health Organization launched a global initiative, known as aDSM (active TB drug safety monitoring and management) to better describe the safety profile of new treatment regimens for drug-resistant tuberculosis (TB) in real-world settings. However, comprehensive surveillance is difficult to implement in several countries. The aim of the aDSM project is to demonstrate the feasibility of implementing national aDSM registers and to describe the type and the frequency of adverse events (AEs) associated with exposure to the new anti-TB drugs. Following a pilot study carried out in 2016, official involvement of TB reference centres/countries into the project was sought and cases treated with bedaquiline- and/or delamanid-containing regimens were consecutively recruited. AEs were prospectively collected ensuring potential attribution of the AE to a specific drug based on its known safety profile. A total of 309 cases were fully reported from 41 centres in 27 countries (65% males; 268 treated with bedaquiline, 20 with delamanid, and 21 with both drugs) out of an estimated 781 cases the participating countries had committed to report by the first quarter of 2019.

Data about delayed tuberculosis diagnosis in Northern Russia are scarce yet such knowledge could enhance the care of tuberculosis. The Arkhangelsk region is situated in the north of Russia, where the population is more than one million residents.

Результаты применения деламанида в лечении туберкулеза с множественной и широкой лекарственной устойчивостью возбудителя в Российской Федерации

The objective: to assess detection rates of non-tuberculous mycobacteria (NTM), incidence of mycobacteriosis, and results of mycobacteriosis treatment in Arkhangelsk Oblast from 2010 to 2020.Subjects and Methods. All patients in whom mycobacteria were detected by microscopy and/or culture with a negative result for M. tuberculosis were examined for NTM. Patients with NTM who had two positive cultures and/or clinical findings suggestive of the disease received treatment of mycobacteriosis.Results. In Arkhangelsk Oblast from 2010 to 2020, NTM were detected in 138 people, with an average rate of 1.09 cases per 100,000 population. Mycobacteria belonging to the M. avium complex (M. avium and M. intralcelulare) (MAC) were reported in the majority of cases (56/138; 40%). In 19/138 (14%) patients, the type of NTM could not be determined. The diagnosis of mycobacteriosis was registered in 67/138 (49%) people, with an average rate of 0.53 cases per 100,000 population. In 45/67 (67%) cases, the disease was caused by MAC. In 71/138 (51%) patients with NTM, no mycobacteriosis was diagnosed. Treatment was started in 60/67 (90%) patients with mycobacteriosis, and in 58/60 (97%) the regimen contained clarithromycin. Results were as follows: treatment was completed in 37 (62%) patients, 10 (16%) patients were defaulters, treatment was canceled for medical reasons in 5 (8%) cases, 1 (2%) patient died of mycobacteriosis, 4 (7%) patients died of other causes, 2 (3%) patients were transferred out, and treatment failed in 1 (2%) patient.

The objective: to establish effectiveness and safety of preventive treatment of tuberculosis with fluoroquinolones in children exposed to multidrug-resistant tuberculosis (MDR TB) in their families.Subjects and Methods. A cohort prospective study was conducted in Arkhangelsk Region from January 01, 2011 to December 31, 2021. Children exposed to MDR TB who received or did not receive preventive treatment were enrolled in the study.Results. 286 children aged 0 to 18 years exposed to 939 adult MDR TB patients were included in the study. Of the 286 children, 37 were exposed to more than one adult with MDR TB, 3 children were exposed to 5 cases, 2 children were exposed to 4 cases, 8 children were exposed to 3 cases, and 24 children were exposed to 1 case. Of the 225 children who received preventive treatment with fluoroquinolones, there were no cases of tuberculosis as of March 1, 2024. Among 61 children who received no preventive treatment, there was 1 (1.64%) case of tuberculosis, which corresponded to the rate of 1639.3 per 100,000 contingent. Adverse reactions to fluoroquinolone were reported in 48/225 (21.33%) children, of which 8/225 (3.6%) were serious ones. All adverse reactions resolved.