Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study

Study Overview
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Brief Summary
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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.

Official Title
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Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study

Conditions
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Sepsis, Septic Shock, Bacteremia

Intervention / Treatment
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* Diagnostic Test: PathoRobot/ Patho-Doc Test result


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspicion of sepsis The drawning of blood cultures Age >18 years Exclusion Criteria: Children (<18 years) Patients who are not hospitalized and sent home after ED admission Duplicate blood cultures from the same bacteraemia episode (7days between positives with the same organism, or 24h for different organisms) Patients from who blood cultures are drawn on Friday evening (17h) or Saturday during intervention periods

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Quasi-experimental intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: New diagnostic results NOT available<br>Patients with suspected sepsis are included. Blood samples will be collected and analysed with the new diagnostics. However, results will not be communicated. Only the results of routine blood cultures will be availabtle to the treating physician. No intervention will take place, care is provided according to normal routine practices. | |
| Experimental: New diagnostic results available<br>Patients with suspected sepsis are included. Blood samples will be collected and analysed with the new diagnostics. Results will be communicated via telephone by the consultant microbiologist and the electronic medical file to the treating physician. Results of routine blood cultures will also be available for all patients. Results of the new diagnostics are expected earlier, and the treating physician is able to make an earlier decision in terms of antibiotic therapy if he/she deems it necessary. | Diagnostic Test: PathoRobot/ Patho-Doc Test result<br>* Test results of the new diagnostics will be available to the treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at study completion, 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time to appropriate, species-specific antibiotic therapy | Time period between collection of blood cultures until the first administration of species-specific antibiotic therapy | at study completion, 10 months | 
| In-hospital mortality | In-hospital mortality | 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 | 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 | 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 | at study completion, 10 months | 
| 30-day all cause mortality | Number of patients with 30-day all cause mortality | at study completion, 10 months | 
| Length-of-stay | Length of hospital stay | at study completion, 10 months | 
| Length of ICU stay | Length of stay in an Intensive Care Unit | at study completion, 10 months | 
| Destination at Discharge | Destination after discharge (home, rehabilitation home, nursing home, ...) | at study completion, 10 months |