MDR-TB cohort study

The study is part of the joint project "No1Lost - Kompetenznetzwerk Therapieadhärenz MDR-TB" and is funded by the Federal Ministry of Health (BMG).

Multidrug-resistant (MDR) and rifampicin-resistant (RR) tuberculosis (MDR/RR-TB) poses a particular challenge for patients, those treating them and the public health system. The psychosocial circumstances, frequent concomitant diseases, adverse drug reactions and the duration and complexity of drug therapy make care considerably more difficult. A retrospective long-term analysis in 2 German treatment centers showed that up to 25% of treatment results were not reproducible and therefore unsuccessful due to treatment discontinuation or change of residence with an unknown destination.

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The Germany-wide, multicenter MDR/RR-TB cohort study aims to investigate the causes of treatment discontinuation in order to identify starting points for improvements in the care of this vulnerable patient group.

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The incidence of multidrug-resistant (MDR) TB has also risen significantly in parallel with the total number of cases. Compared to the previous year (2021: 77 cases, 2.6 %), the number of MDR-TB cases more than doubled in 2022 (166 cases, 5.7 %), with the highest proportion among patients born in one of the post-Soviet states (29.8 % vs. 1.7 % among those born in Germany). Pre-extensively resistant (pre-XDR-TB) and XDR-TB occurred in 33 and 4 cases respectively. The current statistics on tuberculosis cases are recorded by the Robert Koch Institute (RKI), which evaluates and publishes them in the Epidemiological Report at the end of the following year. On World Tuberculosis Day, which takes place every year on March 24, the RKI publishes a bulletin on tuberculosis in which the statistically recorded case numbers of the previous year are presented.

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Study design

• Total duration of studies: 01.07.2024 - 31.12.2027
• Study type: multicenter, prospective and retrospective
• Participants adults: (≥18 years) with MDR/RR-TB
  Prospective period: start of therapy from 2025
• Retrospective period: start of therapy in 2022
• Observation period: up to 36 months
• Study centers: 20-25 in Germany
• Recruitment target: 150 prospective, 75 retrospective

Study objectives

‍Primarystudy objectives

• Establishment of a prospective cohort of MDR/RR-TB patients in Germany
• Determination of differentiated therapy results  
• Analysis of factors influencing treatment outcomes, in particular treatment discontinuation

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Secondary goals

• Comparison of new shortened MDR/RR-TB therapies (6-9 months) with individualized therapy (approx. 18 months)

• Analysis of barriers to the implementation of the German TB treatment guidelines in healthcare practice

• Description of the existing care structures for MDR/RR-TB in Germany

Procedure and survey

Prospective cohort:

• Inclusion of new MDR/RR-TB cases after consent and pseudonymization

• Data collection on the course of inpatient illness and therapy (on admission and discharge from hospital)

• Follow-up phase over the course of outpatient therapy (every 3 months until completion of therapy)

• Follow-up phase for follow-up (every 6 months until the end of the study)

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The following are recorded:  

• Course of the disease and therapy (incl. symptoms, side effects, complications)

• Concomitant diseases and other risk factors

• Laboratory, pathogen and radiological diagnostics, resistance testing

• Demographic and socio-medical characteristics

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Retrospective cohort:

• Analysis of anonymized hospital data from the year 2022

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The following are recorded:  

• Key features of the course of the disease and therapy

• Concomitant diseases and important risk factors

• Laboratory, pathogen and radiological diagnostics, resistance testing

• Key demographic and socio-medical characteristics

• Treatment structure and environment of the study centers

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Recruitment monitor

In order to transparently present the ongoing development of the MDR/RR-TB cohort study within No1Lost, we publish current recruitment figures here at regular intervals.

This gives the specialist public, our networks and the funding body a quick insight into the latest developments in the study:

Status: October 15, 2025

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About the partners in the cohort study

As part of the No1Lost joint project, CAPNETZ STIFTUNG is responsible for setting up and conducting the multicenter cohort study on MDR/RR tuberculosis. In doing so, the foundation relies on its long-established study infrastructure - including its quality-assured IT platform for central, multicenter data collection in accordance with European data protection standards.

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The German Central Committee against Tuberculosis (DZK e.V.), which contributes its networks, clinical expertise and experience in TB care, is the scientific lead of the project. The study centers of the No1Lost cohort study were recruited from the MDR-TB network of the DZK e. V.. This network includes pneumology and infectious disease clinics throughout Germany (link), which have many years of experience in the treatment of tuberculosis - especially multidrug-resistant forms. Many of these clinics are already part of the CAPNETZ study network, which means that existing structures and experience can be optimally utilized.

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The Justus Liebig University Giessen is providing scientific advice with an in-depth focus on socio-medical influencing factors. Charité Berlin is involved in the study by providing scientific advice on planning the statistical analyses and conducting the study.  

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