MDR-TB cohort study

The study is part of the collaborative project “No1Lost – Competence Network Therapy Adherence MDR-TB” and is funded by the Federal Ministry of Health (BMG).

The multidrug-resistant (MDR) and rifampicin-resistant (RR) tuberculosis (MDR/RR-TB) presents a particular challenge for patients, healthcare providers, and public health services. Psychosocial circumstances, frequent comorbidities, adverse drug reactions, as well as the duration and complexity of the drug therapy considerably complicate care. A retrospective long-term analysis in two German treatment centers showed that up to 25% of therapy outcomes could not be traced due to treatment discontinuation or a change of residence to an unknown destination and were therefore not successful.

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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 areas for improvement in the care of this vulnerable patient group.

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Parallel to the total number of cases, the incidence of multidrug-resistant (MDR) TB has also risen significantly. Compared to the previous year (2021: 77 cases, 2.6%), more than double the number of MDR-TB cases were recorded 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 drug-resistant (pre-XDR TB) and XDR TB occurred in 33 and 4 cases, respectively. The Robert Koch Institute (RKI) currently collects statistics on tuberculosis cases, which it analyzes and publishes in its Epidemiological Report at the end of the following year. On World Tuberculosis Day, which takes place each year on March 24, the RKI publishes a bulletin on tuberculosis presenting the statistically recorded case numbers from the previous year.

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Study design

• Total study duration: July 1, 2024 – December 31, 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 outcomes  
• Analysis of factors influencing therapy outcomes, particularly treatment discontinuation

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Secondary objectives

• 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 therapy guidelines in care practice

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

Procedure and data collection

Prospective cohort:

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

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

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

• Follow-up phase for observation (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)

• Comorbidities 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:  

• Essential characteristics of the course of illness 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 consortium partners in the cohort study

As part of the No1Lost joint project, the CAPNETZ Foundation is responsible for setting up and conducting the multicenter cohort study on MDR/RR tuberculosis. To this end, the foundation draws on its long-established study infrastructure, including its quality-assured IT platform for centralized, multicenter data entry in accordance with European data protection standards.

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The German Central Committee for the Fight Against Tuberculosis (DZK e.V.) is responsible for the scientific management of the project, contributing its networks, clinical expertise, and experience in TB care. The study centers for the No1Lost cohort study were recruited from the MDR-TB network of the DZK e.V. This network comprises pulmonology and infectious disease clinics throughout Germany (link) that have many years of experience in the treatment of tuberculosis, particularly multidrug-resistant forms. Many of these clinics are already part of the CAPNETZ study network, which allows existing structures and experience to be utilized optimally.

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The Justus Liebig University Giessen provides scientific advice with a deeper focus on socio-medical influencing factors.
Charité Berlin is involved in the study by providing scientific advice on the planning of the statistical analyses and the implementation of the study.  

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