NO1LOST: Cohort study seeks strategies for the successful treatment of tuberculosis (TB)
Study Portal
BACKGROUND
Improve therapy adherence for successful Tuberculosis treatment outcome
Germany has a low incidence of tuberculosis (TB). However, the relatively high number of treatment relapses among TB patients indicates suboptimal treatment adherence and a suboptimal healthcare structure. The No1Lost project, a comprehensive collaborative initiative funded by the Federal Ministry of Health (BMG), aims to enhance TB treatment care in a targeted manner. This will be achieved by establishing a “treatment adherence competence network” and conducting research into relevant risk factors. The project’s primary focus is a prospective cohort study, which is being conducted in collaboration with the German Central Committee against Tuberculosis (DZK eV), the Justus Liebig University in Giessen and the CAPNETZ STIFTUNG.
TB is considered a less frequent infectious disease in Germany, the number of cases has been increasing recently. Despite the availability of effective drugs, there are a number of challenges associated with treatment, including resistance to anti-TB drugs and severe side effects, which can lead to poor adherence or premature discontinuation of treatment, resulting in clinical deterioration in individuals.
The effectiveness of TB treatment is strongly influenced by social and socio-economic conditions, which also affect adherence. Several factors have been suggested to determine the outcome of comprehensive TB care. For example, a preparatory study showed that clinical care currently depends heavily on the individual commitment of the specialists involved, and that socio-medical support is often underfunded. One of the objectives is therefore to improve adherence to TB treatment by establishing a socio-medical TB competence network with a registry.
Cohort study to identify risk factors for treatment discontinuation in multidrug-resistant tuberculosis (MDR-TB) and rifampicin-resistant tuberculosis (RR-TB)
The prospective MDR-TB cohort study, which is being conducted as part of the No1Lost joint project, is expected to yield tangible results. The objective of the MDR-TB cohort study is to record and analyze the current clinical and social care structure for MDR-TB patients in German treatment centers. This will be achieved by utilizing data on the course of the disease, the course of therapy, and clinical, structural and socioeconomic risk factors. The results will provide an invaluable foundation for the development of a “treatment adherence competence network,” which will serve as a crucial tool for the long-term enhancement of treatment outcomes for MDR-TB in Germany. It is important to note that the success rate of TB therapies is less than 80%, with multi-drug resistant TB having a success rate between 60 and 70%. This is often caused by treatment discontinuation. The cohort study will also investigate the risk factors for treatment discontinuation, such as a lack of understanding of the disease or a lack of social support and socio-medical services.
STUDY OBJECTIVES
The primary objective of the study is to establish a prospective cohort of patients with MDR-/RR-TB patients to describe treatment success and the influence of possible risk factors on treatment success and treatment discontinuation.
The goals in detail are as follows:
Primary
- Establishment of a prospective cohort of MDR/RR-TB patients
- Description of treatment success and treatment discontinuation rates in the prospective MDR/RR-TB cohort
- Description of the influence of possible risk factors on treatment success and treatment discontinuation
Secondary
- Evaluation of new shortened 6-9-month MDR/RR combination therapies (especially BpaLM – bedaquiline, pretomanid, linezolid and moxifloxacin) compared to 18-month individual MDR/RR-TB therapy on treatment success in Germany
- Evaluation of the guideline adherence of the participating centers in the context of MDR/RR-TB treatment
- Description of the existing care and socio-medical structure for MDR/RR-TB in German treatment centers
TIME FRAME
01.07.2024 – 31.12.2027
STUDY PARTICIANTS
The study will enroll approximately 150 adult patients being treated for newly diagnosed multidrug-resistant tuberculosis at participating study sites. Approximately 100 participants will receive a shortened course of therapy over a period of six to nine months. Approximately 50 cases will be treated individually over a period of 18 months. Subsequent follow-up observations will be conducted at 3, 9, 15 and 21 months post-treatment to assess disease progression, treatment course and outcomes. The study is expected to start in the first quarter of 2025.
Additionally, data from 75 MDR-TB patients will be retrospectively collected at the participating study centers as a comparison cohort.
STUDY LOCATIONS
15 – 25 treatment centers from the MDR/RR-TB network of the DZK eV
STUDY TYPE/METHODOLOGY
Multicenter prospective/retrospective and longitudinal observational study in Germany
VISITING STRUCTURE
PARTNER
Scientific project management:
Dr. Ralf Otto-Knapp
German Central Committee for Combating Tuberculosis (DZK eV)
Walterhöferstraße 11, D-14165 Berlin
Project management:
CAPNETZ STIFTUNG
Dipl.-Chem. Grit Barten-Neiner, MBA
Hannover Medical School
Carl-Neuberg-Str. 1, D-30625 Hannover
Study management and coordination:
CAPNETZ STIFTUNG
Dipl.-Volkswirt Frank Eberhardt
Hannover Medical School
Carl-Neuberg-Str. 1, D-30625 Hannover
Coordinating cooperation/network partner:
Prof. Dr. Torsten Bauer
German Central Committee for Combating Tuberculosis (DZK eV)
Walterhöferstraße 11, D-14165 Berlin
Cooperation/network partners:
Prof. Dr. Michael Knipper
Justus Liebig University Giessen
Institute for the History of Medicine
Professorship for Global Health, Migration and Cultural Studies in Medicine
Kreditgesterner Weg 52, D-35392 Giessen
Scientific and biomedical consulting:
Dr. Matthias Gröschel
Charité – Universitätsmedizin Berlin
Infectious Diseases, Pulmonology and Intensive Care Medicine
Chariteplatz 1, D-10117 Berlin
IT and database:
Michael Wallner
2mt Software GmbH
Webspirit Systems GmbH
Engelbergstraße 8, D-89077 Ulm