Clinical trial NCT04103203: Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study
Official title: Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Septic Shock
Bacteremia
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: School of Medicine, University of Zagreb
name: Molzym
name: AIT Austrian Institute of Technology GmbH
name: BEE Robotics
name: University of Warwick
name: Claude Bernard University
name: Axo Science
First posted: 2019-09-25
Enrollment: 1978
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental intervention
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Median time from specimen collection/arrival in the laboratory until antibiotic regimen change
timeFrame: at study completion, 10 months
Secondary outcomes:
measure: Median time to appropriate, species-specific antibiotic therapy
timeFrame: at study completion, 10 months
measure: In-hospital mortality
timeFrame: at study completion, 10 months
measure: Time to organism identification
timeFrame: at study completion, 10 months
measure: Time to effective therapy
timeFrame: at study completion, 10 months
measure: Time to optimal therapy
timeFrame: at study completion, 10 months
measure: 30-day all cause mortality
timeFrame: at study completion, 10 months
measure: Length-of-stay
timeFrame: at study completion, 10 months
measure: Length of ICU stay
timeFrame: at study completion, 10 months
measure: Destination at Discharge
timeFrame: at study completion, 10 months
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Hasselt University
name: Inge C Gyssens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.