Fast Assay for Pathogen Identification and Characterization – Prospective Study

Overview

The FAPIC project will develop a diagnostic system that will identify pathogens and charachterize virulence and resistance. A prospective study will be performed in which blood samples will be collected of patients with suspected sepsis in order to evaluate the diagnostic system. In routine care, blood is drawn of these patients for culture in order to identify the causative pathogen. This process takes 3-5 days. During the study, one extra blood sample will be collected with the same venipuncture, with each blood culture. Afterwards, routine diagnosis by blood culture is followed. Blood samples will be send to the research laboratories for determination of sensitivity and specificity. The system will not be used in the clinic.

Full Title of Study: “Fast Assay for Pathogen Identification and Characterization – Prospective Study”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2017

Clinical Trial Outcome Measures

Primary Measures

  • Detection of pathogens and its virulence factors and susceptibility genes
    • Time Frame: 1 year
    • Sensitivity, specificity, and accuracy of the molecular system compared to blood culture.

Secondary Measures

  • Population outcome during routine procedures
    • Time Frame: 1 year
    • Insights on routine hospital procedures using blood culture and outcomes on the study population such as TAT, antimicrobial use, time to antimicrobial change, in-hospital stay, and mortality by collection of patient data in the medical records.

Participating in This Clinical Trial

Inclusion Criteria

  • Older than 18 years
  • Suspicion of bacteremia

Exclusion Criteria

  • Children (<18 years)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hasselt University
  • Collaborator
    • AIT Austrian Institute of Technology GmbH
  • Provider of Information About this Clinical Study
    • Principal Investigator: prof. dr. Inge Gyssens, Prof. dr. – Hasselt University
  • Overall Official(s)
    • Inge C Gyssens, MD, PhD, Principal Investigator, Hasselt University

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.

Martin GS. Sepsis, severe sepsis and septic shock: changes in incidence, pathogens and outcomes. Expert Rev Anti Infect Ther. 2012 Jun;10(6):701-6. doi: 10.1586/eri.12.50. Review.

Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.

Yoshikawa TT. Antimicrobial resistance and aging: beginning of the end of the antibiotic era? J Am Geriatr Soc. 2002 Jul;50(7 Suppl):S226-9. Review.

Corona A, Colombo R. Towards the end of the antibiotic era: let's save the ancient soldier Colistin! Intensive Care Med. 2013 Sep;39(9):1660-1. doi: 10.1007/s00134-013-2955-3. Epub 2013 May 22.

Hede K. Antibiotic resistance: An infectious arms race. Nature. 2014 May 1;509(7498):S2-3. doi: 10.1038/509S2a.

Bush K. Alarming β-lactamase-mediated resistance in multidrug-resistant Enterobacteriaceae. Curr Opin Microbiol. 2010 Oct;13(5):558-64. doi: 10.1016/j.mib.2010.09.006. Epub 2010 Oct 1. Review.

Zankari E, Hasman H, Cosentino S, Vestergaard M, Rasmussen S, Lund O, Aarestrup FM, Larsen MV. Identification of acquired antimicrobial resistance genes. J Antimicrob Chemother. 2012 Nov;67(11):2640-4. doi: 10.1093/jac/dks261. Epub 2012 Jul 10.

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