Fast Assay for Pathogen Identification and Characterization - Prospective Study
- Conditions
- Sepsis
- Registration Number
- NCT03025802
- Lead Sponsor
- Hasselt University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 238
- Older than 18 years
- Suspicion of bacteremia
- Children (<18 years)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection of pathogens and its virulence factors and susceptibility genes 1 year Sensitivity, specificity, and accuracy of the molecular system compared to blood culture.
- Secondary Outcome Measures
Name Time Method Population outcome during routine procedures 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.
Trial Locations
- Locations (2)
Jessa Hospital
🇧🇪Hasselt, Limburg, Belgium
University of Zagreb Medical School
🇭🇷Zagreb, Croatia