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Completed

NCT Number: NCT03025802

Fast Assay for Pathogen Identification and Characterization - Prospective Study

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.

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Key information

Conditions

Sepsis Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessa Hospital, Hasselt, Limburg, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older than 18 years
  • Suspicion of bacteremia

Exclusion criteria

  • Children (<18 years)

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • AIT Austrian Institute of Technology GmbH
  • Jessa Hospital
  • University of Zagreb

Registry information

Acronym: FAPIC

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 20, 2017
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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