Fast Assay for Pathogen Identification - Quasi-Experimental Intervention Study

NCT ID: NCT04103203

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1978 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-04-30

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.

Conditions

Sepsis; Septic Shock; Bacteremia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

New diagnostic results NOT available

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

New diagnostic results available

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.

Group Type: EXPERIMENTAL

PathoRobot/ Patho-Doc Test result

Intervention Type: DIAGNOSTIC_TEST

Test results of the new diagnostics will be available to the treating physician.

Interventions

PathoRobot/ Patho-Doc Test result

Test results of the new diagnostics will be available to the treating physician.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

School of Medicine, University of Zagreb

UNKNOWN

Sponsor Role: collaborator

Molzym

UNKNOWN

Sponsor Role: collaborator

AIT Austrian Institute of Technology GmbH

OTHER

Sponsor Role: collaborator

BEE Robotics

UNKNOWN

Sponsor Role: collaborator

University of Warwick

OTHER

Sponsor Role: collaborator

Claude Bernard University

OTHER

Sponsor Role: collaborator

Axo Science

UNKNOWN

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

prof. dr. Inge Gyssens

Prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inge C Gyssens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

Jessa Hospital

Hasselt, Limburg, Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 26903338 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26903336 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28101605 (View on PubMed)

Other Identifiers

19.51/Infect.19.02

Identifier Type: -

Identifier Source: org_study_id