Actively Recruiting

Phase Not Applicable
All Genders
ID06576258

The Clinical Impact of Cobasae Eplex Blood Culture Panels for Diagnosing Bacteremia and Fungemia

Led by University Hospital, Antwerp · Updated on 2025-04-02

200

Participants Needed

1

Research Sites

4 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

This research aims to improve the diagnosis and clinical management of bloodstream infections (BSIs) across patients of all ages and genders who have positive blood cultures. The study evaluates the impact of rapid molecular testing using the cobasae eplex blood culture panels compared to standard culture methods. The goal is to see how quickly the most effective antibiotic treatment can be started and how this affects patient outcomes such as hospital stay length and mortality. Participants with positive blood cultures are divided into two groups. The intervention group receives testing with the cobasae eplex multiplex PCR in addition to conventional culture methods, while the control group uses only standard culture methods. The eplex system uses three panels to detect 56 organisms and 10 antibiotic resistance genes rapidly, providing results within hours. This study assesses the performance, user-friendliness, and turnaround times of the eplex compared to traditional methods. Throughout the study, researchers will monitor the time from hospital admission to the start of effective antibiotic treatment, length of hospital and ICU stays, antibiotic use intensity, and patient outcomes such as 30-day mortality and readmission rates. The study involves collecting blood culture samples, performing microbiological tests, and tracking treatment changes and patient health for up to 30 days after discharge. The overall aim is to understand if rapid molecular testing improves care for patients with bloodstream infections.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

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, bloodstream infection episodes caused by gram-negative organisms only
Not Eligible

You will not qualify if you...

  • Patients deceased at the time of the positive blood culture
  • Patients receiving comfort care or with an estimated survival less than one month before sepsis
  • Patients with positive blood cultures within the past 14 days
  • Patients with suspected contaminant blood culture bottles (skin commensals or environmental contaminants) without other infection sites

AI-Screening

AI-Powered 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 - A few hours to up to two weeks

Participants have blood samples collected and tested using the cobas eplex multiplex PCR and standard culture methods to identify bloodstream infections and antibiotic resistance.

1 blood culture collection visit (in-person)

Long-term Monitoring

Duration - From hospital admission until 30 days after discharge

Participants are observed to assess the impact of rapid diagnostic testing on antimicrobial treatment effectiveness, hospital stay, and survival up to 30 days after discharge.

Follow-up visits as part of routine care

Trial Site Locations

Total: 1 location

1

University Hospital Antwerp

Edegem, Antwerp, Belgium, 2650

Actively Recruiting

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Research Team

S

Sien De Koster, PhD

T

Thomas Demuyser, PhD

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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