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

NCT06576258 | Recruiting FDA Device

• 1 other identifier: EGDE-3742
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Bloodstream Infection

Keywords

syndromic diagnostic testing; bloodstream infection; cobas eplex

Outcome Measures

Primary Outcomes (1)

• The time to most effective antimicrobial treatment

  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.

  From hospital admission until 30 days after discharge of the patient

Secondary Outcomes (6)

• Performance of the cobas eplex instrument

  From positive blood culture until eplex (up to a few hours) and SOC culture results (up to two weeks) are available

• The impact of the eplex result on the time to first antibiotic optimization

  From hospital admission until the time of first optimization of antimicrobial treatment for the bloodstream infection (up to one week after hospital admission))

• The impact of the eplex result on the hospital and ICU length-of-stay

  From hospital admission until discharge in a single episode of hospitalization, assessed up to one year

• The impact of the eplex result on 30-day, all cause mortality

  From the start of the BSI episode until 30 days after

• The impact of the eplex result on antibiotic intensity score at 96 hours after Gram staining

  From hospital admission until 96 hours (day 4) after Gram staining

Other Outcomes (2)

• The impact of the eplex result on the health care costs

  From hospital admission until discharge in a single episode of hospitalization, assessed up to one year

• The impact of the eplex result on patient management

  From enrolment until discharge, assessed up to one year

Study Arms (1)

Intervention group (eplex implementation)

EXPERIMENTAL

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.

Diagnostic Test: cobas eplex multiplex PCR

Interventions

cobas eplex multiplex PCR DIAGNOSTIC_TEST

Positive blood culture samples from the intervention group are subjected to cobas eplex multiplex PCR in addition to the SOC culture methods.

Intervention group (eplex implementation)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Veerle Matheeussen, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sien De Koster, PhD

CONTACT

+32 3 821 36 72; Sien.DeKoster@uza.be

Thomas Demuyser, PhD

CONTACT

+32 3 436 82 86; thomas.demuyser@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 28, 2024
• Study Start: November 19, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)