The Clinical Impact of Cobas® Eplex Blood Culture Panels for the Diagnosis of Bacteremia and Fungemia
NCT Number: NCT06576258
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bloodstream Infection
Interventions: DIAGNOSTIC_TEST: cobas eplex multiplex PCR
Sponsor: University Hospital, Antwerp
Collaborators: Roche Diagnostics GmbH
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-11
Completion Date: 2025-12
Locations: University Hospital Antwerp, Edegem, Antwerp, 2650, Belgium

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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., 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., 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)., 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., 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., From hospitalization during the BSI episode until 30 days after discharge
Other Outcome Measures: The impact of the eplex result on the health care costs, Use of health economics models to determine the potential difference in cost based on the length of stay, 30-day all-cause mortality and duration of antimicrobial treatment in the control group and the intervention group., 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, Determine potential difference in time in patient management between the control group and the study group by monitoring the removal of catheters, additional diagnostic investigations, infection control measures., From enrolment until discharge, assessed up to one year