Clinical trial NCT03841162: Fast Assay for Pathogen Identification and Characterization
Official title: Fast Assay for Pathogen Identification and Characterization - Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Sepsis
Septic Shock
Keywords: Blood Cultures
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: University of Zagreb
name: Molzym
name: AIT Austrian Institute of Technology GmbH
name: BEE Robotics
name: University of Warwick
name: Claude Bernard University
name: Axo Science
First posted: 2019-02-15
Enrollment: 1957
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected sepsis, for whom blood cultures are drawn.

Brief summary: Sepsis is a life-threatening disease caused by a dysregulated host response to infection. This can lead to organ-dysfunction and septic shock, which is a subset of sepsis where underlying abnormalities increase mortality remarkably. Blood cultures are the gold standard for identifying pathogens in the bloodstream (bacteremia). It is based on cultivation techniques which, theoretically, can detect a single pathogenic cell from a patient sample. However, blood cultures have serious limitations, such as long time to result (3-7 days). This leads to the fact that only a small fraction of the patients obtain a correct diagnosis and in further consequence get the optimal antimicrobial treatment. Patients with sepsis should get antimicrobial treatment within the hour. Thus, physicians start treatment empirically, with broad-spectrum antibiotics. This puts a selective pressure on pathogens and has led to an increased amount of antibiotic resistance. Faster diagnostics are necessary to ensure an immediate and targeted treatment. In the EU-funded FAPIC project, two diagnostic systems that can be used with direct sample material from patients will be developed, avoiding the time-consuming cultivation of pathogens.

In this study, the evaluation of the rapid diagnostics will be performed in patients with sepsis, suspected of bacteremia. To this aim, the performance of the diagnostic systems will be evaluated using blood samples that are collected in parallel with blood cultures. In addition, clinical data of the patients will be collected. In routine care, two blood culture sets (2x2 bottles) per patient are collected. One extra blood samples (EDTA, 9 ml) will be sampled with each blood culture set, totaling 2 samples per patient. In this study, patients presenting at the Emergency Department (ED), and the department of infectious diseases/nephrology will be included. The results will be used to estimate the performance, sensitivity, and specificity of the diagnostic systems compared to blood culture. Furthermore, in order to determine the severity of sepsis and to describe the patient population, clinically relevant parameters and laboratory parameters (ferritin, HLA-DR, serum lactate, SOFA score) will be assessed to determine its association with severity of disease and patient mortality. Evaluation will be done exclusively in the lab, and will not be used directly for the diagnosis or management of patients. Standard care will still be provided.

Detailed description: This study is a follow-up study of the first prospective study performed in 2017 in the same hospital. The ClinicalTrials.gov ID number of the previous study was NCT03025802.

Eligibility criteria: Inclusion Criteria:

* Patients for whom blood cultures are drawn
* Age ≥ 18

Exclusion Criteria:

* Age \< 18
* Patients who are not hospitalized and sent home after ED admission
* Patients from the haematology department
* Duplicate blood cultures from the same bacteraemia episode (blood cultures drawn \<7 days after first blood culture)

Primary outcomes:
measure: Confirmed bacteremia based on positive blood cultures (SOFA score)
timeFrame: 7 days
measure: Confirmed bacteremia based on positive blood cultures (Serum Lactate)
timeFrame: 7 days
measure: Confirmed bacteremia based on positive blood cultures (Ferritin)
timeFrame: 7 days
measure: Test performance
timeFrame: 1 year
Secondary outcomes:
measure: Length of Stay (SOFA score)
timeFrame: 1 year
measure: Length of Stay (Serum Lactate)
timeFrame: 1 year
measure: Length of Stay (Ferritin)
timeFrame: 1 year
measure: 30-day Mortality (Sofa score)
timeFrame: 30 days
measure: 30-day Mortality (Serum Lactate)
timeFrame: 30 days
measure: 30-day Mortality (Ferritin)
timeFrame: 30 days
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Radboud University Medical Center
name: Inge C Gyssens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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