Value of the LightCycler® SeptiFast Test MGRADE for the Pathogen Detection in Neutropenic Hematological Patients
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.
Inclusion Criteria:

 1. Patient with hematological disease and neutropenia < 500/µl (or < 1000/µl, if
 criterion 5A is fulfilled)

 2. Known or acute infection, or suspected infection, or sepsis, which clinically
 indicates investigation by blood culture

 3. Time-frame after diagnosis or suspicion of infection or sepsis: < 72 hours

 4. Species causing infection not known before inclusion

 5. Patient fulfils criterion A or/and B

 A. Indication for an initiation of antimicrobial therapy in patients with febrile
 neutropenia

 -  Neutropenia <500/µl or <1000/µl if decline to <500/µl is expected in the next
 48h.

 -  Single (oral) temperature of ≥ 38.3°C, or temperature ≥ 38.0°C lasting for at
 least 1h or measured twice within 12h.

 -  No evidence of non-infectious cause of fever (blood products, drugs reactions,
 etc)

 B. At least two of the following criteria:

 -  Temperature >38°C or <36°C

 -  Heart rate >90 beats/minute

 -  Respiratory rate >20 breaths/minute or PaCO2 <32 mmHg / 4,3 kPa

 6. Patient is able to provide written informed consent

 Exclusion Criteria:

 1. Moribund patients with survival expectation < 24h

 2. Younger than 18 years

 3. Patient is not able to provide informed consent

 4. Patients not suitable for study participation in the opinion of investigator