Fast Assay for Pathogen Identification and Characterization - Prospective Study (FAPIC)

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.

Study Overview

• Status: Completed
• Conditions: Sepsis

• Study Type: Observational
• Enrollment (Actual): 238

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Hospital
• Croatia
  • Zagreb, Croatia, 10000
    • University of Zagreb Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A prospective cohort will be set up to determine and evaluate the performance of the diagnostic system. The cohort will consist of 250 patients (~500 blood culture sets) with suspicion of bacteremia, for whom routine blood cultures are ordered.

Description

Inclusion Criteria:

• Older than 18 years
• Suspicion of bacteremia

Exclusion Criteria:

• Children (<18 years)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Population outcome during routine procedures	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.	1 year

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital; University of Zagreb; AIT Austrian Institute of Technology GmbH
• Investigators: Principal Investigator: Inge C Gyssens, MD, PhD, Hasselt University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. doi: 10.1046/j.1532-5415.50.7s.2.x.
• 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. No abstract available.
• Hede K. Antibiotic resistance: An infectious arms race. Nature. 2014 May 1;509(7498):S2-3. doi: 10.1038/509S2a. No abstract available.
• Bush K. Alarming beta-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.
• 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.

Helpful Links

• FAPIC project website

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 16, 2017
• First Posted (Estimate): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 19, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Bacteremia; Sepsis; Rapid diagnostics; Molecular diagnosis; Pathogen identification
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: 16.120/infect16.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO