The Clinical Impact of Cobas® Eplex Blood Culture Panels for the Diagnosis of Bacteremia and Fungemia

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Patients with onset of BSI at the emergency department or general wards

• Patients hospitalized from blood draw (at least 24h)

• For pediatric patient only BSI episodes caused by gram-negative organisms

Locations
Other Locations
Belgium
University Hospital Antwerp
RECRUITING
Edegem
Contact Information
Primary
Sien De Koster, PhD
Sien.DeKoster@uza.be
+32 3 821 36 72
Backup
Thomas Demuyser, PhD
thomas.demuyser@uza.be
+32 3 436 82 86
Time Frame
Start Date: 2024-11-19
Estimated Completion Date: 2025-12
Participants
Target number of participants: 200
Treatments
Experimental: Intervention group (eplex implementation)
Positive blood culture samples from the intervention group are subjected to eplex multiplex PCR in addition to the SOC culture methods. cobas® eplex system with syndromic panels is a medical device designed for in vitro diagnostic use and is CE-IVD registered. The medical device is used in accordance with the terms of the CE mark.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Antwerp
Collaborators: Roche Diagnostics GmbH

This content was sourced from clinicaltrials.gov