NCT06624618

Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit

Rapid Molecular Detection of Sepsis in Whole Blood

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Bloodstream Infection

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-10-03
• Last updated: 2024-10-03

Locations

1 site across 1 country: Netherlands