Actively Recruiting

Age: 18Years +
All Genders
ID06624618

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients are included when routine blood cultures are ordered for diagnosis of bloodstream infections.
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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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