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NCT03025802 Clinical Trial

Fast Assay for Pathogen Identification and Characterization - Prospective Study

Sepsis Clinical Trial

— FAPIC  

Official title:
Fast Assay for Pathogen Identification and Characterization - Prospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03025802
Other study ID # 16.120/infect16.04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date June 2017

Study information
Verified date May 2018
Source Hasselt University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 238
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Older than 18 years

- Suspicion of bacteremia

Exclusion Criteria:

- Children (<18 years)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Jessa Hospital Hasselt Limburg
Croatia University of Zagreb Medical School Zagreb

Sponsors (4)
Lead Sponsor Collaborator
Hasselt University AIT Austrian Institute of Technology GmbH, Jessa Hospital, University of Zagreb

Countries where clinical trial is conducted

Belgium,  Croatia, 

References & Publications (8)

Bush K. Alarming ß-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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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