SEPTICISION - Automated point-of-care precision diagnostics in the "golden first hour" of sepsis

SEPTICISION - Automated point-of-care precision diagnostics in the "golden first hour" of sepsis - SEPTICISION

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00028972

Enrollment

250

Registered

2022-11-24

Start date

2023-01-02

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41.9

Interventions

Group 1: In patients with suspected bloodstream infection, a blood sample is taken at diagnosis and after 2-3 days and a nasal swab is taken. These are examined with a point-of-care device newly devel

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Hospitalized patients >= 18 years with initial suspicion of sepsis/bloodstream infection Existing consent for the study participation of the patient or the caregiver

Exclusion criteria

Exclusion criteria: Age < 18 years Pregnant women Disabled people unable to consent Lack of consent to participate in the study

Design outcomes

Primary

Measure	Time frame
Successful and concordant detection of the causative pathogen in comparison to standard sepsis diagnostics, and inflammatory parameters using the novel POC device	—

Secondary

Measure	Time frame
- Recording of the point in time when the POC result is available - Calculation of the time difference to standard diagnostics - Determination of the time difference between a possible initiation of therapy after POC diagnostics compared to standard diagnostics - Registration of the proportion of study patients for whom the early availability of the POC result would have resulted in a change in the course of treatment, in particular antibiotic therapy (substance, start of therapy, duration of therapy) (retrospective evaluation) - Correlation of pathogen semiquantification with time-to-positivity of blood cultures and patient mortality and complication rate of bloodstream infection - Creation of a score using the results of the POC diagnostics and the standard methods for risk stratification regarding mortality and complications to guide further patient management - Analysis of non-concordant results of standard pathogen diagnostics compared to POC diagnostics -- Different pathogen detection with both methods -- Pathogen detection with only one method -- Additional pathogen detection with POC diagnostics - Correlation of the nasal microbiome with disease progression/severity of infection - Correlation of the pathogen load reduction in the blood in the first 48-72 h using POC diagnostics -- for standard diagnostics -- with the course of the disease -- Necessity of further therapeutic measures -- Patient mortality and complication rate	—

Measure

Time frame

- Recording of the point in time when the POC result is available - Calculation of the time difference to standard diagnostics - Determination of the time difference between a possible initiation of therapy after POC diagnostics compared to standard diagnostics - Registration of the proportion of study patients for whom the early availability of the POC result would have resulted in a change in the course of treatment, in particular antibiotic therapy (substance, start of therapy, duration of therapy) (retrospective evaluation) - Correlation of pathogen semiquantification with time-to-positivity of blood cultures and patient mortality and complication rate of bloodstream infection - Creation of a score using the results of the POC diagnostics and the standard methods for risk stratification regarding mortality and complications to guide further patient management - Analysis of non-concordant results of standard pathogen diagnostics compared to POC diagnostics -- Different pathogen detection with both methods -- Pathogen detection with only one method -- Additional pathogen detection with POC diagnostics - Correlation of the nasal microbiome with disease progression/severity of infection - Correlation of the pathogen load reduction in the blood in the first 48-72 h using POC diagnostics -- for standard diagnostics -- with the course of the disease -- Necessity of further therapeutic measures -- Patient mortality and complication rate

—

Countries

Germany

Contacts

Public ContactStudienassistenten/innen

Universitätsklinikum Freiburg, Klinik für Innere Medizin II, Abteilung Infektiologie

info@if-freiburg.de+4976127018280

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026