Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sepsis, Bloodstream Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Rapid Molecular Detection of Sepsis in Whole Blood
Overview
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.
Primary outcome measures
- Development and validation of rapid diagnostics tests for detection of bacterial DNA in sepsis [Time frame: 2 years]
- Patterns of bacterial DNA dynamics over time [Time frame: 2 years]
Secondary outcome measures (1)
- 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 [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
-Patients are included when routine blood cultures are ordered for diagnosis of bloodstream infections.
Exclusion criteria
-N/A
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Netherlands · 1 center
- Maastricht University Medical Center — Maastricht
Identifiers
NCT: NCT06624618 · 2023-0344