An observational study in Sepsis and Bloodstream Infection, sponsored by Maastricht University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Maastricht University Medical Center · Observational
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 300 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients at the Intensive Care Unit (ICU) of Maastricht University Medical Center (MUMC) are eligible.
-Patients are included when routine blood cultures are ordered for diagnosis of bloodstream infections.
Exclusion Criteria:
-N/A
Development and validation of rapid diagnostics tests for detection of bacterial DNA in sepsis
The tests will report presence of bacterial DNA by giving a specific bacterial species name.
Time frame: 2 years
Patterns of bacterial DNA dynamics over time
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.
Time frame: 2 years
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
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Maastricht University Medical Center