The performance and clinical impact of two diagnostic systems will be evaluated using whole blood samples that are collected in parallel with samples for blood culture. As the rapid diagnostic systems will have the largest impact on severely ill patients (in need of a fast diagnosis) with bacterial infection, the evaluation will be performed in patients suspected of bacteraemia. During the study the new systems will be used in parallel with routine blood cultures. In alternating periods of 1 month, the results of the diagnostic system will be communicated to treating physicians (intervention) or not revealed (control). Blood culture results will be reported throughout the complete study period. Patients with suspected sepsis at the Emergency Department (ED), the department of infectious diseases/nephrology, and the department of haemodialysis will be included. In routine care, two blood culture sets (2x2 bottles) per patient are collected. One extra blood sample (EDTA tube, 9 ml of blood) will be sampled for each routine set of blood cultures. In addition, the clinical data of the patients will be collected. The samples will be sent to the clinical laboratory where samples are tested with the new systems during regular working hours in batches of 8 samples per run (2-3 runs per day). On average, 10%-20% of the blood cultures drawn on the presumption of bacteraemia yield bacterial pathogens. Previous data show that 13% of patients yield positive blood cultures. Thus, in order to collect blood samples of 100 new episodes of bacteraemia approximately 1000 patients (2000 blood cultures + 1000 EDTA tubes) have to be collected for each system (2000 patients in total). The results of the systems will be used to evaluate the clinical utility of the system regarding time to antibiotic treatment change and bacteraemia management. The system will be used directly for the diagnosis of patients, resulting in a possible change of treatment strategy. However, routine blood culture practices will still be done during the whole study period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,978
Test results of the new diagnostics will be available to the treating physician.
Jessa Hospital
Hasselt, Limburg, Belgium
Median time from specimen collection/arrival in the laboratory until antibiotic regimen change
Time period between collection of blood cultures until the first change in antibiotic regimen
Time frame: at study completion, 10 months
Median time to appropriate, species-specific antibiotic therapy
Time period between collection of blood cultures until the first administration of species-specific antibiotic therapy
Time frame: at study completion, 10 months
In-hospital mortality
In-hospital mortality
Time frame: at study completion, 10 months
Time to organism identification
Time period between collection of blood cultures until the time to identification of a causative organism with the new diagnostics and with blood cultures
Time frame: at study completion, 10 months
Time to effective therapy
Time period between collection of blood cultures until the first administration of antibiotic therapy effective againts the causative organism
Time frame: at study completion, 10 months
Time to optimal therapy
Time period between collection of blood cultures until the first administration of antibiotic therapy that is optimal for patient recovery
Time frame: at study completion, 10 months
30-day all cause mortality
Number of patients with 30-day all cause mortality
Time frame: at study completion, 10 months
Length-of-stay
Length of hospital stay
Time frame: at study completion, 10 months
Length of ICU stay
Length of stay in an Intensive Care Unit
Time frame: at study completion, 10 months
Destination at Discharge
Destination after discharge (home, rehabilitation home, nursing home, ...)
Time frame: at study completion, 10 months
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