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

NCT ID: NCT06576258

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-19
• Study Completion Date: 2025-12-31

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.

Detailed Description

Bloodstream infections (BSIs) impose a considerable burden on patients and healthcare systems due to the need for hospital admission, extended stays, additional diagnostic tests and specific treatments. Receiving inappropriate empirical antibiotic therapy can increase the risk of renal and hepatic toxicity, antibiotic resistance, opportunistic infections and mortality. Therefore, early identification of the causative pathogens and their resistance patterns is of utmost importance.

The gold standard for diagnosis of BSIs is through blood cultures. To detect bacteremia or fungemia, blood from patients is collected and incubated in blood culture bottles. When using conventional culture methods, a positive blood bottle is investigated using direct microscopic investigation, gram-staining, inoculation of selective and non-selective agars, MALDI-TOF identification, rapid antimicrobial susceptibility testing (AST) and standardized AST methods. These methods require several (manual) steps and days of turn-around-time. Following the collection of a blood culture, time to result depends on several factors such as the time needed for transporting the blood bottles and loading in the incubator, the growth rate of bacteria or fungi as well as the time to obtain the identification and AST result.

Rapid diagnostic tests to improve the time to appropriate antimicrobial therapy have been developed. Most tests involve organism identification and genotypic resistance profiles. Rapid molecular diagnostic testing, such as multiplex PCR methods, enable early identification of bacteria or fungi and their antimicrobial resistance genes (results within less than 2 hours after initiation of the test). This helps minimize the time needed to initiate effective antimicrobial therapy. Commercial diagnostic systems to accelerate the identification and detection of antibiotic resistance genes of causative pathogens in BSI have been developed. Examples include Cepheid® GeneXpert, BioFire® FilmArray®TM, and Roche eplex®. The system used in this study, the eplex system, is a random access multiplex PCR platform combining extraction of nucleic acids and rapid RT-PCR. Three Blood Culture Identification (BCID) panels are used to identify the disease-causing organisms: Gram-positive panel, Gram-negative panel and Fungal Pathogen panel. These panels are designed to detect 56 different organisms covering 95% of pathogens commonly associated with BSIs and 10 common antibiotic resistance genes.

The objective of this study is to assess the impact of rapid molecular testing on positive blood cultures with the cobas® eplex system (Roche) on antibiotic therapy and patient outcome.

In this study, we prospectively evaluate the performance of the eplex system for pathogen identification and detection of resistance markers compared to routine SOC for bloodstream infections. The potential impact of the eplex on time to optimization (inititiation, discontinuation, escalation or de-escalation) of antimicrobial therapy and patient outcome will be evaluated.

In summary, Finally, this study will evaluate the potential benefits of implementing CE-IVD registered syndromic diagnostic testing of bloodstream infections.

Conditions

Bloodstream Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention group (eplex implementation)

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.

Group Type: EXPERIMENTAL

cobas eplex multiplex PCR

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

cobas eplex multiplex PCR

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veerle Matheeussen, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University Hospital Antwerp

Edegem, Antwerp, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Sien De Koster, PhD

Role: CONTACT

Sien.DeKoster@uza.be

+32 3 821 36 72

Thomas Demuyser, PhD

Role: CONTACT

thomas.demuyser@uza.be

+32 3 436 82 86

Facility Contacts

Thomas Demuyser, PhD

Role: primary

thomas.demuyser@uza.be

+32 3 436 82 86

Sien De Koster, PhD

Role: backup

Sien.DeKoster@uza.be

+32 3 821 36 72

Other Identifiers

EGDE-3742

Identifier Type: -

Identifier Source: org_study_id