About a year ago, the recruitment phase of the trial “DigiSep – Optimization of sepsis therapy based on patient-specific digital precision diagnostics” started. Now the project, led by the Department of Anesthesiology and Intensive Care Medicine at the University Hospital Essen, has reached another important
milestone: since mid-March 2023, half of the planned 410 trial patients have been recruited. Only in February, 43 patients were added, so that the recruitment target can be reached as planned in summer 2023.
Interest in participating in the DigiSep trial has increased in recent months with more than the originally planned 20 hospitals applying to participate, currently 25 hospitals are enrolled in the trial. This emphasises the high level of clinical interest in the topics of sepsis and digital precision diagnostics. “We are overwhelmed by the demand from clinics for the new technology. We did not expect such interest. This shows that there are high expectations for diagnostics using next-generation sequencing (NGS). Therefore, I would like to express my gratitude once again to the Innovation Committee of the Joint Federal Committee, which is funding the project with more than 3 million euros,” said Univ. Prof. Dr. med. Thorsten Brenner, Director of the Department of Anesthesiology and Intensive Care Medicine at the University Hospital Essen.
The research consortium expects the DigiSep trial to provide insights on how the use of digital diagnostics affects the mortality of patients with sepsis, the duration of their antibiotic therapy and their length of stay in intensive care. The aim is to improve treatment options for sepsis – the most severe form of infectious disease, which affects more than 300,000 people and causes 75,000 deaths each year in Germany alone.
The DigiSep project is led by the Clinic for Anesthesiology and Intensive Care Medicine at the University Hospital Essen as consortium leader, in close cooperation with the Chair of Health Economics & Health Management at the University of Bielefeld, the Coordination Centre for Clinical Studies (KKS) and the Institute for Medical Biometry (IMBI) at the University Hospital Heidelberg as well as with the health insurance companies AOK Rheinland/Hamburg, BARMER and Techniker Krankenkasse. The biotechnology company Noscendo GmbH provides its DISQVER® analysis platform as a technical partner.
In half of the involved patients (n=205), the blood is examined with the help of DISQVER® in addition to routine diagnostics. The platform can identify more than 16,000 microbes, including 1,500 described pathogens (bacteria, DNA viruses, fungi and parasites) within 24 hours. To do so, the cell-free DNA in the blood is analysed using next-generation sequencing, a new, particularly fast method for DNA analysis. DISQVER® compares the information from the sample with a clinical genome database using bioinformatic algorithms. Within a few hours, there is clarity about the type and quantity of pathogens in the blood, so that anti-infectives can be used precisely.
For the other half of the involved patients (n=205), only the current standard diagnostics are used. The intensive care physicians are supported by a panel of infectious disease experts.
DigiSep c/o Universitätsklinikum Essen
Achim Struchholz
Achim.struchholz@uk-essen.de
Tel. +49 (0) 201-723-2885
Universitätsklinikum Heidelberg
Doris Rübsam-Brodkorb
presse@med.uni-heidelberg.de
Tel. +49 (0) 6221-56-4537
Universität Bielefeld
Sandra Sieraad
medien@uni-bielefeld.de
Tel. +49 (0) 521-106-4170
AOK Rheinland/Hamburg – DIE GESUNDHEITSKASSE
Kirsten Simon
presse@rh.aok.de
Tel. + 49 (0) 211-8791-28219
BARMER
Sunna Gieseke
presse@barmer.de
Tel. +49 (0) 0800-333004 99- 1421
Techniker Krankenkasse
Gabriele Baron
gabriele.baron@tk.de
Tel. +49 (0) 40-69 09 17 83
Noscendo GmbH
Dr. Peter Haug
peter.haug@noscendo.com
Tel. +49 (0)2066-506 87 82