Do patients with sepsis or septic shock benefit from digital pathogen diagnostics in addition to blood culture? Is this diagnostic approach cost-neutral due to shorter treatment time and reduced long-term effects? These and other questions were investigated in the trial "DigiSep - Optimization of sepsis therapy based on patient-specific digital precision diagnostics". The trial has now been completed, and the promising results have been submitted to the German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) for further review. The G-BA is the highest decision-making body in the joint self-governance of the German health care system and decides, among other things, which diagnostic methods may be offered as a service by health insurance companies.
Three years in duration, 410 randomly selected patients with sepsis or septic shock, 24 participating hospitals, more than three million euros in funding - these are the key data of the DigiSep study. Behind them is an ambitious project. "Recruiting people with sepsis or septic shock is not easy. And that was just one of the many challenges of this trial. The clinical and health economic evaluation of the results was also highly complex," says Prof. Dr. Thorsten Brenner, head of the research project and director of the Department of Anesthesiology and Intensive Care Medicine at the University Hospital Essen. "We are therefore very pleased to be able to present valuable results. We owe this to the close, cooperative partnership between renowned German hospitals and high-profile consortium partners, including leading German health insurance companies. I would like to express my sincere thanks to everyone involved in this outstanding collaboration."
As scheduled, the DigiSep consortium submitted the results to the G-BA at the end of February 2025. The insightful clinical findings will now be further reviewed. The results of the health economic analysis will also be included in the final evaluation by the G-BA. These are based on data from the participating health insurance companies AOK Rheinland/ Hamburg, BARMER and Techniker Krankenkasse and cover around one third of the cases. A presentation of the trial results will take place in April 2025 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in Vienna, one of the world's largest medical conferences for infectious diseases. Subsequently, the results will be published in a high-ranking medical journal to make them easily accessible to everyone involved in the care of septic patients. The participating health insurance companies have already indicated their interest in investigating the continuation of the new diagnostic approach in health care to provide their policyholders with a forward-looking pathogen diagnostic tool for sepsis or septic shock.
Besides the Department of Anaesthesiology and Intensive Care Medicine at Essen University Hospital, the DigiSep trial involved 23 other German hospitals, the Department of Health Economics & Health Care Management at the University of Bielefeld, the Coordinating Center for Clinical Trials (Koordinierungszentrum für Klinische Studien, KKS) and the Institute for Medical Biometry (IMBI) both at the University Hospital of Heidelberg, as well as the health insurance companies AOK Rheinland/Hamburg, BARMER and Techniker Krankenkasse. As a technical partner, the diagnostics company Noscendo GmbH provided its digital precision test DISQVER®.
About the DigiSep trial
The trial “DigiSep – Optimizing sepsis therapy based on patient-specific digital precision diagnostics” investigated how the use of digital diagnostics affects the mortality of sepsis patients, the duration of their antibiotic therapy, and their length of stay in the intensive care unit. For this purpose, blood samples from half of the study participants (n=205) were analyzed with the DISQVER® platform in addition to the standard procedures. Using next-generation sequencing (NGS) and bioinformatics, DISQVER® can identify more than 16,000 microbes, including 1,500 described pathogens (bacteria, DNA viruses, fungi, and parasites), within 24 hours. Within a few hours, DISQVER® provides information on the type and quantity of pathogens in the blood, so that targeted anti-infective treatment can be initiated. For the other half of the participating patients (n=205), only current standard diagnostics were used. The attending intensive care physicians were supported by a panel of experts.
More information https://www.digisep.de
Sepsis
In the case of sepsis, the body's immune response to an infection, e.g. with bacteria or viruses, can be so severe that organs and tissues are massively damaged or fail completely. This makes the disease life-threatening. In Germany, up to 300,000 persons suffer from sepsis every year; at least 85,000 die from or with sepsis.
Further information on sepsis:
https://www.sepsiswissen.de/
Innovation fund project that aims to help raise awareness of sepsis
Sepsis Symposium - Center for Intensive Care Medicine Metropolis Ruhr (ZIMR)
Clinical symposium taking place on World Sepsis Day
https://www.deutschland-erkennt-sepsis.de/
Campaign of the Patient Safety Action Alliance
Press Contacts
DigiSep
c/o Universitätsklinikum Essen
Burkhard Büscher
Burkhard.Buescher@uk-essen.de
Tel. +49 (0) 201-723-2115
Universitätsklinikum Heidelberg
Dr. Stefanie Seltmann
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
Anika Jurkuhn
presse@rh.aok.de
Tel. +49 (0) 211-8791-1236
BARMER
Athanasios Drougias
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