Status:
UNKNOWN
Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting
Lead Sponsor:
Nexus DX
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in ...
Eligibility Criteria
Inclusion
- Subject is able and willing to provide written informed consent
- Subject is 18 years of age or older
- Subject is presenting with symptoms suggestive of bacterial infection
- Subject is presenting with two or more of the following symptoms suggestive of systemic inflammatory response syndrome (SIRS):
- Body temperature less than 36°C (96.8°F) or greater than 38°C (100.4°F);
- Heart rate greater than 90 beats per minute;
- Respiratory rate greater than 20 breaths per minute, or an arterial partial pressure of carbon dioxide (pCO2) less than 4.3 kPa (32 mmHg);
- White blood cell count less than 4,000 cells/mm3 (4 x 109 cells/L) or greater than 12,000 cells/mm3 (12 x 109 cells/L);
- A normal white blood cell count with the presence of greater
- than 10% immature neutrophils.
Exclusion
- Subjects less than 18 years of age;
- Subjects who do not present with a minimum of two symptoms suggestive of SIRS, as defined above
- Subjects unable or unwilling to provide written informed consent
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04529733
Start Date
September 15 2020
End Date
March 30 2021
Last Update
August 28 2020
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