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NCT06576258
The Clinical Impact of Cobas® Eplex Blood Culture Panels for the Diagnosis of Bacteremia and Fungemia
NA trial testing cobas eplex multiplex PCR in Bloodstream Infection in 200 participants. Currently enrolling.
1 November 2025
Quick facts
| Lead sponsor | University Hospital, Antwerp |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 200 |
| Start date | 19 November 2024 |
| Primary completion | 1 November 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- cobas eplex multiplex PCR
Conditions studied
- Bloodstream Infection — all drugs for Bloodstream Infection →
Sponsor
University Hospital, Antwerp
Who can join
Eligibility, any sex, with Bloodstream Infection. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The time to most effective antimicrobial treatment
Time frame: From hospital admission until 30 days after discharge of the patient
The difference in time to most effective/targeted antimicrobial treatment in the intervention group and control group. An antimicrobial therapy is defined as optimal when it is the narrowest spectrum agent with acceptable activity against the isolated pathogen based on the culture or eplex results, taking into account the toxicity of the antibiotic and the patient medical conditions.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06576258
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other University Hospital, Antwerp trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06576258 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Antwerp
- Last refreshed: 27 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06576258.
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