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
Authors' conclusion
The DOOR/RADAR score as primary endpoint was not significantly improved by mNGS. Exploratory secondary analyses revealed improvements in secondary endpoints.
Study context
- Population
- Patients with sepsis or septic shock in 24 ICUs across Germany24 ICUs
- Participants
- 200 vs 189
- Comparison
- Intervention vs Control
- Interventionn = 200
- Controln = 189reference
- Primary endpoint
- DOOR/RADAR score
- Follow-up
- 28 days after sepsis onset
Methodological detailsopen-label, multicentre
- Open-label
- Multicentre
Primary result
As reported in the abstract
Intervention
3.21
± 1.54
Control
3.49
± 1.51
95% CI - 0.58 to 0.03
Secondary outcomes
Duration of mechanical ventilation · reduced · exploratory
(95% CI - 5.03 to - 0.34)
Time to shock resolution · faster · exploratory
(95% CI - 3.75 to - 0.04)
| Outcome | Intervention | Control | P value |
|---|---|---|---|
| Health-related quality of life (EQ-5D-5L) · 90 daysImproved · exploratory | 0.312 ± 0.386 | 0.208 ± 0.373 | P = 0.047 |
Healthcare costs (subgroup with claims data, 33.2% of patients) · 180 days
- Healthcare costs did not differ
Original publication
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. Intensive Care Med. Published 30 June 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →