AB-PSP-001
Research type
Research Study
Full title
A multicenter, device clinical study for the early diagnostic of sepsis and potential impact on antibiotic management based on serial Pancreatic Stone Protein (PSP) measured using the AbioSCOPE® in critically ill patients at high risk of sepsis.
IRAS ID
241359
Contact name
David Brealey
Contact email
Sponsor organisation
Andrew Oliver CRA Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 14 days
Research summary
Severe infections & sepsis are major health problems associated with high levels of illness and death. Any delay in initiating treatment, like antibiotics, can lead to a poorer prognosis for the patient. Infections are suspected based primarily upon patients symptoms & laboratory tests. Laboratory tests such as blood culture take days to complete and are frequently unhelpful. This study is looking at a test which can lead to earlier detection of Sepsisby checking levels of a blood marker called Pancreatic Stone Protein(PSP). \nThe abioSCOPE® is in vitro diagnostic (IVD) device, which provides rapid medical test results, including PSP. It is composed of a fully automated fluorescent microscope, a mounting plate (the abioDISC), onto which is placed a single-use disposable IVD capsule. Following preparation, the sample is placed into the IVD capsule and the abioDISC is inserted into the abioSCOPE®. The principle underlying the abioSCOPE® screening system is the biomolecular interactions that occurs within the capsules. The biological specimen, typically a patient’s venous serum or capillary whole blood sample is diluted with a solution composed of fluorescently labelled biomolecules. The sample is deposited into a capsule where it fills the biosensors inside through capillary action. Within the biosensors the biomolecules diffuse, interact and form fluorescent molecular complexes. A fluorescence signal is emitted from the biosensors upon excitation of these molecular complexes and analysed in the abioSCOPE®. The amplitude of this fluorescent signal is proportional to the analyte concentration in the patient. In a few minutes, the results are saved onto a Secure Digital card (SD card). The abioSCOPE® can be used by any healthcare professional and does not require extensive training. Therefore, the test can be performed more rapidly than traditional laboratory tests which look at other biomarkers. PSP test may have superior accuracy for early detection of sepsis based upon previous clinical studies.\nThis study will look at abioSCOPE® PSP measurements twice daily in 300 adult(age 18 or over)patients admitted to intensive care unit(ICU)with a high risk of sepsis, in comparison to standard clinical procedures. Study patients will be looked at with regard to sepsis diagnosis & patients clinical outcome until they are discharged, 30 days after study inclusion or death, whichever happens first. \nInvestigators will NOT have access to the PSP values. They will follow their routine regarding treatment of patients. PSP values obtained will not be used to influence the decisions made by the investigators. The first Endpoint Adjudication Committee(EAC) will be blinded to the investigators decisions regarding antibiotics starting and being reduced or stopped, they will base their evaluation on the clinical data & the abioSCOPE® PSP values. The second EAC will make its retrospective evaluation solely based on abioSCOPE® PSP values.\n
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
18/LO/0951
Date of REC Opinion
11 Jun 2018
REC opinion
Favourable Opinion