Bloodstream InfectionNCT06576258
The Clinical Impact of Cobas® Eplex Blood Culture Panels for the Diagnosis of Bacteremia and Fungemia
A study testing cobas eplex multiplex PCR in people with Bloodstream Infection, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bloodstream Infection
- What is being tested?
- cobas eplex multiplex PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Nov 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp
Edegem, Antwerp, 2650
Thomas Demuyser, PhD, +32 3 436 82 86, thomas.demuyser@uza.be
Sien De Koster, PhD, +32 3 821 36 72, Sien.DeKoster@uza.be
About this study
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.
Read the 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
- Being tested
- cobas eplex multiplex PCR
- Keywords
- syndromic diagnostic testing, bloodstream infection, cobas eplex
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cobas eplex multiplex PCRDiagnostic test
Positive blood culture samples from the intervention group are subjected to cobas eplex multiplex PCR in addition to the SOC culture methods.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: cobas eplex multiplex PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hospital admission until 30 days after discharge of the patient
Secondary outcomes (6)
Performance of the cobas eplex instrument
Determine the agreement of the eplex and routine SOC culture results (sensitivity/specificity).
Determination of user-friendliness and hands-on time of the cobas eplex system. Determination of time-to-result of the eplex compared to routine culture. The time of the eplex identification result is compared to the MALDI-TOF result obtained by the SOC culture method. The time of the eplex AST result is compared to the standardized AST result that is obtained by the SOC culture methods.
Measured: 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
Time to first antibiotic optimization (escalation/de-escalation/change in antibiotic class/discontinuation of therapy) in the control group and the intervention group.
Definition time to first optimization of antibiotic treatment: the time between the Gram stain result and the first optimization of antibiotic treatment (escalation/de-escalation/change in antibiotic class/discontinuation or initiation of therapy).
Definition escalation: corresponds to the start of an effective therapy if none had been started or to broadening the bacterial spectrum of the antibiotic therapy.
Definition de-escalation: defined as narrowing of the antibacterial spectrum of the antibiotic therapy or the stop of at least one antibiotic.
Definition change in antibiotic class: change in antibiotic class with a similar spectrum of activity.
Measured: 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
The hospital and ICU length-of-stay of the control group and the intervention group are compared.
Definition hospital length-of-stay: time between patient's hospital admission and discharge in a single episode of hospitalization.
Definition ICU length-of-stay: time between the patient's ICU admission and discharge in a single episode of hospitalization.
Measured: 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
The mean 30-day, all cause mortality rate of the control group and the intervention group is compared.
Definition 30-day, all cause mortality: Mortality from all causes occurring within 30 days of the start of the BSI episode (first positive blood culture).
Measured: 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
The antibiotic intensity scores in the control group and the intervention group are compared.
Definition antibiotic intensity score: The sum of the number of days the patient received of each antibiotic multiplied by the antibiotic spectrum. This value is used to define antibiotic exposure at 96h after Gram staining.
An antibiotic spectrum index (ASI) matrix was developed by Gerber et al. (2017). To obtain an aggregate ASI for a patient on a single day, the ASI of all antibiotics prescribed are summed.
Measured: From hospital admission until 96 hours (day 4) after Gram staining
The impact of the eplex result on 30-day readmission
The 30-day readmission rates of the control group and intervention group are compared.
Definition 30-day readmission: The 30-day readmission rate is defined as the number of admissions for bloodstream infections for which there was at least one subsequent hospital admission within 30 days after discharge.
Measured: From hospitalization during the BSI episode until 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start19 Nov 2024
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Veerle Matheeussen, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576258
- Sponsor's protocol ID
- EGDE-3742
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual patient data will not be shared. Aggregated patient data will be shared when the findings of the study are made publically available through publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Impact of Cobas® Eplex Blood Culture Panels for the Diagnosis of Bacteremia and Fungemia
- ClinicalTrials.gov ID
- NCT06576258
- Acronym / sponsor ID
- EGDE-3742
- Conditions
- Bloodstream Infection
- Keywords
- syndromic diagnostic testing, bloodstream infection, cobas eplex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group (eplex implementation) | Experimental | Diagnostic Test: cobas eplex multiplex PCRPositive 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cobas eplex multiplex PCRPositive blood culture samples from the intervention group are subjected to cobas eplex multiplex PCR in addition to the SOC culture methods. | Diagnostic test | Intervention group (eplex implementation) |
Primary outcome
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.
6 secondary outcomes
Performance of the cobas eplex instrument
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From hospital admission until 96 hours (day 4) after Gram staining
The impact of the eplex result on 30-day readmission
Time frame: From hospitalization during the BSI episode until 30 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No. Individual patient data will not be shared. Aggregated patient data will be shared when the findings of the study are made publically available through publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veerle Matheeussen, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cobas eplex multiplex PCR in people with Bloodstream Infection, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sien De Koster, PhD (+32 3 821 36 72, Sien.DeKoster@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to most effective antimicrobial treatment (time frame: From hospital admission until 30 days after discharge of the patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.