Sepsis Clinical Trial
Official title:
Value of the LightCycler® SeptiFast Test MGRADE for the Pathogen Detection in Neutropenic Hematological Patients
The overall objective of this study is to assess the clinical value of the SeptiFast Test as an adjunct to traditional microbiological, clinical, and other laboratory assessments in early detection and identification of a potential pathogen and therefore early targeted antimicrobial management of neutropenic hematological patients with suspected infection or sepsis.
Infections, including sepsis, continue to be a major cause of morbidity and mortality in
patients with hematologic diseases. Early diagnosis of infection, rapid identification of
the causative pathogen(s), and prompt initiation of appropriate antimicrobial treatment (the
first 24 hours are most critical) all have a major impact on mortality.
The LightCycler® SeptiFast Test MGRADE (SeptiFast Test) is an in vitro nucleic acid
amplification test for the direct detection and identification of DNA from bacterial and
fungal microorganisms in human EDTA whole blood. The SeptiFast test can detect nucleic acids
from the most common pathogens (approximately 90%) responsible for hospital-associated
bacteremia. The test is used in conjunction with the patient's clinical presentation and
established microbiological assays and other laboratory markers as an aid in antimicrobial
treatment decision making for patients with suspected sepsis and other bloodstream
infections.
This is a randomized prospective study of the use of the SeptiFast Test as an adjunct to
traditional management of neutropenic haematological patients suspected of having infection
or sepsis. The study will be performed in a two-armed manner. The blood sample for the
SeptiFast Test will be collected from all included patients. However, analysis of the
SeptiFast Test in the control group will only be performed at a later point in time; thus,
in the control group results will not become available until the end of the study and,
therefore, cannot be used for guiding clinical decisions.
Patients complete the study when the episode of infection or sepsis resolves, or the patient
is discharged from a hospital, or the patient died.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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