Fast Assay for Pathogen Identification and Characterization

Completed

• Conditions: Sepsis; Septic Shock; Bacteremia

• Registration Number: NCT03841162
• Lead Sponsor: Hasselt University

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.

Study Timeline

• Study First Submitted: 2019-02-06
• Study Start: 2019-02-12
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Status Verified: 2020-04
• Primary Completion: 2020-04-17
• Study Completion: 2020-04-17
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1957

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmed bacteremia based on positive blood cultures (Ferritin)	7 days	Differences in Ferritin levels between patients with positive blood cultures and patients with negative blood cultures
Test performance	1 year	Performance characteristics (Clinical sensitivity, specificity and accuracy) of a new rapid diagnostic systems
Confirmed bacteremia based on positive blood cultures (Serum Lactate)	7 days	Differences in Serum Lactate levels between patients with positive blood cultures and patients with negative blood cultures
Confirmed bacteremia based on positive blood cultures (SOFA score)	7 days	Differences in SOFA score between patients with positive blood cultures and patients with negative blood cultures.; SOFA: Sequential Organ Failure Assessment; Range 0-4 (better to worse).

Secondary Outcome Measures

Name	Time	Method
Length of Stay (SOFA score)	1 year	Differences in length of stay between patients with high and with low SOFA score SOFA: Sequential Organ Failure Assessment; Range 0-4 (better to worse).
30-day Mortality (Sofa score)	30 days	Differences in 30-day mortality between patients with high and with low SOFA score SOFA: Sequential Organ Failure Assessment; Range 0-4 (better to worse).
Length of Stay (Ferritin)	1 year	Differences in length of stay between patients with high and with low Ferritin levels
30-day Mortality (Ferritin)	30 days	Differences 30-day mortality between patients with high and with low Ferritin levels
30-day Mortality (Serum Lactate)	30 days	Differences 30-day mortality between patients with high and with low Serum Lactate levels
Length of Stay (Serum Lactate)	1 year	Differences in length of stay between patients with high and with low Serum Lactate levels

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium