Actively Recruiting
Rapid Molecular Detection of Sepsis in Whole Blood
Led by Maastricht University Medical Center · Updated on 2024-10-03
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
H
Health Holland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Rapid and accurate diagnosis of sepsis is essential for effective treatment and improving survival rates. Current blood culture methods take 48 hours to 5 days and are unreliable after starting antimicrobial treatment, often leading to broad spectrum antibiotic use which increases resistance. This research aims to develop and validate a new molecular diagnostic test that detects bacterial DNA directly from blood, offering a faster alternative to traditional culture methods. The study focuses on creating and testing rapid diagnostics that identify bacterial DNA causing sepsis within two years. It will also analyze how bacterial DNA levels change over time in patients. Additionally, a physician evaluation panel will compare the new tests' results with current blood culture standards to distinguish true infections from contaminations. Participants will be patients for whom routine blood cultures are ordered to diagnose bloodstream infections. Researchers will collect blood samples and monitor bacterial DNA patterns using the new molecular tests. The study will assess test accuracy and dynamics of infection markers, aiming to improve early pathogen identification and treatment decisions. The total study period for outcomes review is two years.
CONDITIONS
Brief Title
Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients are included when routine blood cultures are ordered for diagnosis of bloodstream infections.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Initial assessment period
Participants undergo diagnostic evaluations including blood cultures ordered as part of routine care to detect bloodstream infections.
1 visit (in-person)
Duration - Up to 2 years
Participants are monitored over time to assess the dynamics of bacterial DNA and validate rapid diagnostic tests for sepsis detection.
Periodic assessments during routine care
Trial Site Locations
Total: 1 location
1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
Actively Recruiting
Research Team
A
Anna Wijen, Msc.
P
Paul Savelkoul, Prof. Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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