Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit

Rapid Molecular Detection of Sepsis in Whole Blood

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06624618

Acronym

RADOS

Enrollment

300

Registered

2024-10-03

Start date

2024-05-01

Completion date

2026-05-01

Last updated

2024-10-03

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

Conditions

Bloodstream Infection, Sepsis

Keywords

Culture-free, Whole blood, Molecular diagnosis, Sepsis, Bloodstream infection, Bacterial DNA

Brief summary

Rapid diagnosis of sepsis is crucial for treatment and survival. Currently, blood culture takes 48 hours-5 days to complete. After starting antimicrobial treatment blood culture results are not reliable. As a result, empirical broad spectrum antimicrobial therapy is mostly used. This implies possible antimicrobial over- or under treatment which is associated with increased antimicrobial resistance development. Early identification of the causative pathogen of sepsis will therefore have a major impact on the adequate treatment and reduction of high mortality rates. To date, there is not a single molecular diagnostic test available on the market to detect all putative causative bacterial pathogens of sepsis. In this study, the investigators will develop and validate a completely new molecular sepsis approach based on pathogen DNA detection, as an alternative to culture.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

-Patients are included when routine blood cultures are ordered for diagnosis of bloodstream infections.

Exclusion criteria

-N/A

Design outcomes

Primary

Measure	Time frame	Description
Development and validation of rapid diagnostics tests for detection of bacterial DNA in sepsis	2 years	The tests will report presence of bacterial DNA by giving a specific bacterial species name.
Patterns of bacterial DNA dynamics over time	2 years	Use of species-specific qPCR primers (either from existing sepsis literature or to be designed) to quantify the DNA load at at least 3 different time points during an infectious episode. Comparison of these loads with infectious parameters used for routine diagnostics and with antibiotic use.

Secondary

Measure	Time frame
Distinguishing between the causative pathogen and contamination by a physician evaluation panel, both for the current gold standard (blood cultures) and the results of new microbiological tests for detecting sepsis pathogens	2 years

Countries

Netherlands

Contacts

Primary ContactAnna Wijen, Msc.

anna.wijen@maastrichtuniversity.nl+31 626882868

Backup ContactPaul Savelkoul, Prof. Dr.

paul.savelkoul@mumc.nl+31 433876610

Outcome results