Actively Recruiting
The Clinical Impact of Cobas® Eplex Blood Culture Panels for the Diagnosis of Bacteremia and Fungemia
Led by University Hospital, Antwerp · Updated on 2025-04-02
200
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Antwerp
Lead Sponsor
R
Roche Diagnostics GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
A quality improvement study on the diagnostics and clinical management of bloodstream infection episodes. Patients of all ages and genders with positive blood cultures collected for standard patient care are included in the study. In the intervention group of patients, positive blood cultures will be analysed with the cobas® eplex (Roche) blood culture panels in addition to conventional, standard-of-care (SOC) culture methods. The control group will include patients with positive blood cultures analysed using conventional, standard-of-care (SOC) culture methods. The study aims to determine the effect of rapid molecular testing using the cobas® eplex blood culture panels (Roche) in the clinical management of bloodstream infections and more specifically the effect of the eplex result on the time to most effective/targeted antibiotic treatment. The primary objective is to investigate the difference in time to most effective antibiotic treatment between the control and intervention group. The secondary aims are to analyze the concordance of results and compare the user-friendliness, hands-on time and turnaround times of the eplex to the SOC culture methods as well as to compare the difference in the length of stay, antibiotic intensity score at 96h after Gram staining and patient outcome (30-day, all cause mortality and 30-day readmission) in the control and intervention group.
CONDITIONS
Official Title
The Clinical Impact of Cobas® Eplex Blood Culture Panels for the Diagnosis of Bacteremia and Fungemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with onset of bloodstream infection at the emergency department or general wards
- Patients hospitalized from blood draw for at least 24 hours
- For pediatric patients, only bloodstream infection episodes caused by gram-negative organisms
You will not qualify if you...
- Patients deceased at the time of the positive blood culture
- Patients in comfort care or with an estimated survival less than one month before sepsis
- Patients with positive blood culture bottles within the past 14 days
- Patients with blood cultures suspected to be contaminated by skin or environmental bacteria without other infection sites
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
Research Team
S
Sien De Koster, PhD
CONTACT
T
Thomas Demuyser, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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