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.
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
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.
Single group
cobas eplex multiplex PCR
Diagnostic testPositive blood culture samples from the intervention group are subjected to cobas eplex multiplex PCR in addition to the SOC culture methods.
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.
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.
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.
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.
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).
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.
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.
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University Hospital, Antwerp
Lead sponsor
Roche Diagnostics GmbH
Collaborator
