NCT04571801: DigiSep

Optimization of Sepsis Therapy Based on Patient-specific Digital Precision Diagnostics

Completed NA Last updated 24 August 2025

What this trial tests

NA trial testing Standard diagnostics in Sepsis in 410 participants. Completed in 23 April 2024.

Timeline

16 March 2022

Primary endpoint
28 March 2024

23 April 2024

Quick facts

Lead sponsor	University Hospital, Essen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	410
Start date	16 March 2022
Primary completion	28 March 2024
Estimated completion	23 April 2024
Sites	22 locations across Germany

Drugs / interventions tested

• Standard diagnostics
• Next Generation Sequencing (NGS)

Conditions studied

• Sepsis — all drugs for Sepsis →
• Septic Shock — all drugs for Septic Shock →

Sponsor

University Hospital, Essen

Who can join

18 and older, any sex, with Sepsis or Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sepsis is triggered by an infection and represents one of the greatest challenges of modern intensive care medicine. With regard to a targeted antimicrobial treatment strategy, the earliest possible pathogen detection is of crucial importance. Until now, culture-based detection methods represent the diagnostic gold standard, although they are characterized by numerous limitations. Culture-independent molecular diagnostic procedures may represent a promising alternative. In particular, the concept of plasmatic detection of circulating, free DNA employing next-generation sequencing (NGS) has shown to be suitable for the detection of disease-causing pathogens in patients with bloodstream infections.

The DigiSep-Trial is a randomized, controlled, interventional, multicenter trial to characterize the effect of the combination of NGS-based digital precision diagnostics, standard-of-care microbiological analyses and optional expert exchanges compared to solely standard-of-care microbiological analyses in the clinical picture of sepsis / septic shock. The study examines in 410 patients (n = 205 per arm) with sepsis / septic shock whether the so-called DOOR-RADAR (Desirability of Outcome Ranking / Response Adjusted for Duration of Antibiotic Risk) score (representing a combined endpoint including the criteria (1) inpatient admission time, (2) consumption of antibiotics, (3) mortality and (4) acute renal failure (ARF)) can be significantly improved, by application of an additional NGS-based diagnostic concept. We also aim to investigate whether the new diagnostic procedure is cost-effective. It is postulated that the inpatient admission time, mortality rate, incidence of ARF, the duration of antimicrobial therapy as well as the costs of complications and outpatient aftercare can be reduced. Moreover, a significant improvement in the quality of life (QoL) of the affected patients can be expected.

Extensive preparatory work suggests that NGS-based diagnostics have higher specificity and sensitivity compared to standard-of-care microbiological analyses for detecting bloodstream infections. This preliminary work for the DigiSep-Trial with the help of an interventional study design provides the optimal basis to establish this new concept as part of the national standard based on the best possible evidence.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Optimization of sepsis therapy based on patient-specific digital precision diagnostics using next generation sequencing (DigiSep-Trial)-study protocol for a randomized, controlled, interventional, open-label, multicenter trial.
   Brenner T, Skarabis A, Stevens P, Axnick J, et al · · 2021 · cited 17× · PMID 34663439 · DOI 10.1186/s13063-021-05667-x