Evidence map›Paper›PMID 42377463›Full record

Trial reportIntensive care medicine2026

Effects of a clinical metagenomics intervention on clinical outcomes, healthcare costs, and health-related quality of life in patients with sepsis or septic shock: results of the randomized-controlled DigiSep trial.

Thorsten Brenner, Annabell Skarabis, Stefan J Schaller, Thilo von Groote, Christian Putensen, Ulf Günther, Martin Sauer, Sebastian O Decker, Fabian Dusse, Manfred Weiss and 16 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Intensive care medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04571801 (Optimization of Sepsis Therapy Based on Patient-specific Digital Precision Diagnostics), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04571801 nacompletednot on this map

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

TypeinterventionalSponsorUniversity Hospital, EssenRan2022 to 2024Enrolled410ConditionsSepsis, Septic ShockArmsStandard diagnostics, Next Generation Sequencing (NGS)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Clinical metagenomics: a call to action.Intensive care medicine · 2026
    Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Thorsten BrennerDepartment of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, Essen, Germany. thorsten.brenner@uk-essen.de.ORCID http://orcid.org/0000-0002-4570-877X
Annabell SkarabisDepartment of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Stefan J SchallerCharité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt Universität Zu Berlin, Department of Anaesthesiology and Intensive Care Medicine (CCM/CVK), Berlin, Germany.
Thilo von GrooteDepartment of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Albert-Schweitzer Campus 1, 48149, Münster, Germany.
Christian PutensenDivision of Intensive Care Medicine, Department of Anesthesiology and Surgical Intensive Care Medicine, Universitätsklinikum Bonn, Bonn, Germany.
Ulf GüntherUniversity Clinic of Anesthesiology, Intensive Care, Emergency Care, Pain TherapyKlinikum Oldenburg, Rahel-Straus-Str. 10, 26133, Oldenburg, Germany.
Martin SauerCentre of Anesthesiology and Intensive Care Medicine, Hospital of Magdeburg, Birkenallee 34, 39130, Magdeburg, Germany.
Sebastian O DeckerDepartment of Anesthesiology, Heidelberg University, Medical Faculty Heidelberg, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany.
Fabian DusseDepartment of Anesthesiology and Intensive Care Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.
Manfred WeissClinic of Anaesthesiology and Intensive Care Medicine, University Hospital Medical School Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Klaudiusz SuchodolskiKlinik für Anästhesiologie und Intensivmedizin, Medizinische Hochschule Hannover, Carl-Neuberg-Straße 1, 30625, Hannover, Germany.
Tim-Philipp SimonDepartment of Intensive Care Medicine, Medical Faculty, RWTH Aachen University, Aachen, Germany.
Peter RosenbergerKlinik für Anästhesiologie und Intensivmedizin, Eberhard-Karls Universität Tübingen, Hoppe Seyler Strasse 3, 72076, Tübingen, Germany.
Onnen MoererKlinik für Anästhesiologie, Universitätsmedizin Göttingen, Robert-Koch-Str. 40, 37075, Göttingen, Germany.
Matthias UnterbergRuhr-Universität Bochum, Knappschaft Kliniken Universitätsklinikum Bochum, Klinik Für Anästhesiologie, Intensivmedizin Und Schmerztherapie, Munich, Germany.
Jens-Christian ScheweDepartment of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Medical Centre Rostock, Schillingallee 35, 18057, Rostock, Germany.
Hendrik BrachtCentral Emergency Services, University Hospital Ulm, Ulm, Germany.
Selina HutzlCoordination Centre for Clinical Trials (KKS), Medical Faculty, Ruprecht-Karls-University, Berliner Straße 10, 69120, Heidelberg, Germany.
Manuel FeißtInstitute of Medical Biometry, University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Ursula MarschallBARMER, Institute for Health System Research, Lichtscheider Str. 89, 42285, Wuppertal, Germany.
Patrick BrandenburgHealth Management Division, Health Care Innovations Department, AOK Rhineland/Hamburg, The Health Insurance Fund, Warnheimer Straße 72, 40468, Düsseldorf, Germany.
Philip StevensNoscendo GmbH, Duisburg, Germany.
Juliana SchmidtDepartment of Health Economics and Health Care Management, School of Public Health, Bielefeld University, Universitätsstraße 25, 33615, Bielefeld, Germany.
Mathias W PletzInstitute of Infectious Diseases and Infection Control and Centre for Sepsis Care and Control, Jena University Hospital/Friedrich Schiller University, Am Klinikum 1, 07740, Jena, Germany.
Marc M BergerDepartment of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
German Society of Anaesthesiology and Intensive Care (GSAIC) Trials Group

Funding

German Innovation Fund 01NVF20013
6 · The paper itself

Abstract

purposeEarly pathogen detection is crucial in sepsis. We hypothesized that detection of microbial circulating cell-free DNA by metagenomic next-generation sequencing (mNGS) improves clinical outcomes and health-related quality of life without increasing healthcare costs.

methodsThis randomized, controlled, interventional, open-label, multicenter trial was conducted in 24 intensive care units across Germany. The intervention group (n = 200) received mNGS diagnostics in addition to standard-of-care microbiology, compared with standard-of-care microbiology alone (control group; n = 189). The primary endpoint was the Desirability of Outcome Ranking/Response Adjusted for Duration of Antibiotic Risk (DOOR/RADAR) score.

resultsThe DOOR/RADAR score was not significantly improved at 28 days after sepsis onset (intervention group: 3.21 ± 1.54; control group: 3.49 ± 1.51; 95% CI - 0.58 to 0.03). However, other secondary endpoints were improved, including a reduced duration of mechanical ventilation (intervention group: 6.6 ± 9.4 days; control group: 9.3 ± 10.6 days; 95% CI - 5.03 to - 0.34) and faster shock resolution (intervention group: 6.9 ± 7.4 days; control group: 8.8 ± 8.5 days; 95% CI - 3.75 to - 0.04). Health-related quality of life at 90 days (EQ-5D-5L) was improved in the intervention group (0.312 ± 0.386) compared with the control group (0.208 ± 0.373; p = 0.047). In the subgroup with available claims data (33.2% of participating patients), healthcare costs over 180 days did not differ.

conclusionThe DOOR/RADAR score as primary endpoint was not significantly improved by mNGS. Exploratory secondary analyses revealed improvements in secondary endpoints. (Funding: German Innovation Fund; ClinicalTrials.gov number, NCT04571801, registration: 25.8.2020).

Indexed as

Health Care CostsMetagenomicsQuality of LifeSepsisShock, SepticAgedFemaleGermanyHigh-Throughput Nucleotide SequencingHumansIntensive Care UnitsMaleMiddle AgedTreatment OutcomeDigiSep trialDOOR/RADAR scoreMetagenomic next-generation sequencingNGSSepsisSeptic shock

Identifiers

PMID42377463
PMCPMC13433414

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.