Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jessa Hospital | OTHER |
| University of Zagreb | OTHER |
| Molzym | UNKNOWN |
| AIT Austrian Institute of Technology GmbH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New diagnostic results NOT available | No Intervention | 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. | |
| New diagnostic results available | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PathoRobot/ Patho-Doc Test result | Diagnostic Test | Test results of the new diagnostics will be available to the treating physician. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Inge C Gyssens, MD, PhD | Hasselt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Hospital | Hasselt | Limburg | 3500 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26903338 | Background | Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. | |
| 26903336 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
| OTHER |
| BEE Robotics | UNKNOWN |
| University of Warwick | OTHER |
| Claude Bernard University | OTHER |
| Axo Science | UNKNOWN |
Quasi-experimental intervention
Not provided
Not provided
Not provided
Not provided
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 |
| Background |
| Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M; Sepsis Definitions Task Force. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):775-87. doi: 10.1001/jama.2016.0289. |
| 28101605 | Background | Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |