NCT06576258 The Clinical Impact of Cobas® Eplex Blood Culture Panels for the Diagnosis of Bacteremia and Fungemia
| NCT ID | NCT06576258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Bloodstream Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-19 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-11-19 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Veerle Matheeussen, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Antwerp
Frequently Asked Questions
Who can join the NCT06576258 clinical trial?
This trial is open to participants of all sexes, studying Bloodstream Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06576258 currently recruiting?
Yes, NCT06576258 is actively recruiting participants. Contact the research team at Sien.DeKoster@uza.be for enrollment information.
Where is the NCT06576258 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT06576258 clinical trial?
NCT06576258 is sponsored by University Hospital, Antwerp. The principal investigator is Veerle Matheeussen, PhD at University Hospital, Antwerp. The trial plans to enroll 200 participants.