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

Recruiting now · Not applicable

Conditions studied: Bloodstream Infection

In brief

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.

Key facts

Study ID

NCT06576258

Run by

University Hospital, Antwerp

People needed

200

Starts

2024-11-19

Expected to finish

2025-12-01

Last updated by the study team

2025-04-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients deceased at the time of the positive blood culture
• Patients in comfort care or with an estimated survival before sepsis of less than one month
• Patients with positive blood culture bottles within the past 14 days
• Patients for which the blood bottles are highly suspected of contaminants (bacterial species belonging to potential skin commensals or known environmental contaminants) and in the absence of any other site of infections.

Where it is running

• University Hospital Antwerp — Edegem, Antwerp, Belgium (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.