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Fast Assay for Pathogen Identification and Characterization - Prospective Study

Fast Assay for Pathogen Identification and Characterization - Prospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03025802
Acronym
FAPIC
Enrollment
238
Registered
2017-01-20
Start date
2017-01-31
Completion date
2017-06-30
Last updated
2018-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

Molecular diagnosis, Pathogen identification, Sepsis, Bacteremia, Rapid diagnostics

Brief 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.

Interventions

None listed

Sponsors

AIT Austrian Institute of Technology GmbH
CollaboratorOTHER
University of Zagreb
CollaboratorOTHER
Jessa Hospital
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Older than 18 years * Suspicion of bacteremia

Exclusion criteria

* Children (\<18 years)

Design outcomes

Primary

MeasureTime frameDescription
Detection of pathogens and its virulence factors and susceptibility genes1 yearSensitivity, specificity, and accuracy of the molecular system compared to blood culture.

Secondary

MeasureTime frameDescription
Population outcome during routine procedures1 yearInsights 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.

Countries

Belgium, Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026