Clinical trial NCT05469048: Near Patient Molecular Testing in Sepsis
Official title: Near Patient Molecular Testing in Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Systemic Inflammatory Response Syndrome
Lead sponsor: Immunexpress
Sponsor class: INDUSTRY
Collaborators: name: Rush University Medical Center
name: Grady Memorial Hospital
name: University of Southern California
First posted: 2022-07-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suspected of sepsis, admitted to an Intensive Care Unit

Brief summary: The purpose of the study is to evaluate the real-time performance of a new host response test (SeptiCyte RAPID) for differentiating sepsis from non-infection/systemic inflammatory response syndrome among patients suspected of sepsis within the first 24 hours of intensive care unit (ICU) admission.

Detailed description: The ability of SeptiCyte RAPID to differentiate sepsis from infection-negative systemic inflammation will be determined using retrospective physician diagnosis performed by an external panel of three physicians not involved with the care of the patients.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old on the date of ICU admission
2. Systemic Inflammatory Response Syndrome (SIRS) present, as defined by the presence of two or more of the following:

   1. Temperature \> 38°C or \< 36°C
   2. Heart Rate \> 90 beat/min
   3. Tachypnea \> 20/min or PaCO2 \< 32 mmHg
   4. WBC count \> 12 000/mm3 or \< 4 000/mm3 or \> 10% immature neutrophils (bands)
3. Consent to study inclusion, either by patient or legal surrogate before study-related sample processing
4. Study sample collection within 24 hours of ICU admission order

Exclusion Criteria:

1. Age less than 18 years old on the day of ICU admission
2. No order to admit to ICU
3. Not physically admitted to ICU
4. Commencement of non-prophylactic antibiotics ≥ 24 hours prior to ICU admission
5. Study sample collection \> 24 hours from ICU admission order
6. No clinical cultures or serologic tests obtained when sepsis was suspected
7. Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours
8. Transfer from another ICU where subject was admitted for ≥ 24 hours.

Primary outcomes:
measure: Real-time evaluation of the diagnostic accuracy of SeptiCyte RAPID in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU.
timeFrame: Time for enrollment, process samples, and collect data, an average of 1 year
Secondary outcomes:
measure: Comparison of diagnostic accuracy between SeptiCyte RAPID and up to 15 other clinical parameters in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU.
timeFrame: Time for enrollment, process samples, and collect data, an average of 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of University of Southern California (USC) and Los Angeles County and USC Medical Center
state: California
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Immunexpress
name: Roy Davis, MD, PhD, MHA
role: STUDY_DIRECTOR
References:
citation: Balk R, Esper AM, Martin GS, Miller RR 3rd, Lopansri BK, Burke JP, Levy M, Opal S, Rothman RE, D'Alessio FR, Sidhaye VK, Aggarwal NR, Greenberg JA, Yoder M, Patel G, Gilbert E, Parada JP, Afshar M, Kempker JA, van der Poll T, Schultz MJ, Scicluna BP, Klein Klouwenberg PMC, Liebler J, Blodget E, Kumar S, Navalkar K, Yager TD, Sampson D, Kirk JT, Cermelli S, Davis RF, Brandon RB. Validation of SeptiCyte RAPID to Discriminate Sepsis from Non-Infectious Systemic Inflammation. J Clin Med. 2024 Feb 20;13(5):1194. doi: 10.3390/jcm13051194.