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Life sciences · Observational Study
ClinicalTrials.gov · October 13, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT06624618). This is a study registration, not published results. Lead sponsor: Maastricht University Medical Center. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 300 participants (ACTUAL). Conditions: Sepsis, Bloodstream Infection. Primary outcome measures: Development and validation of rapid diagnostics tests for detection of bacterial DNA in sepsis , 2 years; Patterns of bacterial DNA dynamics over time , 2 years. 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.