No1Lost: New study protocol on MDR/RR-TB care in Germany published
The No1Lost project has reached an important milestone: the first study protocol has been published in the open access section of the Journal of the International Union against Tuberculosis and Lung Disease (IUTLD). The prospective cohort study described therein examines the clinical and socioeconomic challenges in the treatment of multidrug-resistant and rifampicin-resistant tuberculosis (MDR/RR-TB) in Germany.
Although Germany is a high-income country with a low incidence, the treatment success rate for MDR/RR-TB is currently 55%, which is significantly below the WHO targets. A major driver of these unsatisfactory results is treatment discontinuation and loss to follow-up (LTFU), which increase the risk of relapse and the development of resistance. Since previous data on associated risk factors primarily originate from high-incidence countries, there is a lack of specific evidence for the reality of healthcare provision in Germany.
A major driver of unsatisfactory results is treatment discontinuation and loss to follow-up (LTFU), which increase the risk of relapse and resistance development. Since previous data on associated risk factors primarily originate from high-incidence countries, there is a lack of specific evidence for the reality of healthcare provision in Germany.
The objective of the No1Lost study
The multicenter observational study will include approximately 150 patients in 20 specialized centers in Germany between 2025 and 2027. The primary objective is to identify demographic, clinical, and social determinants associated with treatment discontinuation. Secondarily, the study will evaluate the safety of shortened 6- to 9-month regimens and the feasibility of national guidelines. Strategically, the initiative aims to develop targeted socio-medical interventions based on an improved database. The results will form the basis for future care strategies to ensure therapeutic success in this vulnerable population.
Strong partners for research
The project is being carried out by the CAPNETZ FOUNDATION and scientifically supervised by the DZK, with support from Justus Liebig University Giessen and Charité Universitätsmedizin, Department of Infectious Diseases, Pulmonology, and Intensive Care Medicine.
We would like to thank the Federal Ministry of Health for its kind support of this important study project.
