Performance of the SeptiCyte LAB Test for Antibiotic Stewardship in Mesenteric Ischemia (SPASM)

Study to Evaluate the Performance of the SeptiCyte LAB Test for Antibiotic Stewardship in Mesenteric Ischemia

This study will help determine whether the SeptiCyte LAB test can accurately differentiate between SIRS and actual infections in postoperative patients, potentially reducing unnecessary antibiotic use and improving patient outcomes in cases of acute mesenteric ischemia

Study Overview

• Status: Completed
• Conditions: Intra-abdominal Infection; Acute Mesenteric Ischemia; Sepsis Bacterial; Digestive Inflammation
• Intervention / Treatment: Device: Septicyte Lab Test pre operative; Device: Septicyte Lab Test post operative

Detailed Description

Introduction Early diagnosis of bacterial infections is crucial in intensive care, as conditions such as sepsis and septic shock are emergencies with high mortality rates. Conversely, Systemic Inflammatory Response Syndrome (SIRS) is a deregulated response to an insult without an infectious origin. SIRS is common post-major surgery and complicates the diagnosis between a simple inflammatory response and an actual infection. Although antibiotic therapy is undisputed in septic shock, the rise of antibiotic resistance and the lack of new antibiotics demand a judicious and well-argued prescription in probable sepsis cases. Rapid diagnostics are essential to identify patients who will benefit from empirical antibiotic therapy.

Current Diagnostic Challenges Microbiological documentation remains the gold standard for confirming sepsis or septic shock. However, the delay in obtaining standard bacteriology results poses a risk to patient survival. Biomarkers like CRP and PCT have been proposed for sepsis diagnosis, but their reliability is limited by numerous confounding factors, making them less specific.

The SeptiCyte LAB Test Recent advances in sequencing technology have made molecular biology techniques more accessible and rapid. SeptiCyte LAB is a molecular test based on the quantitative sequencing of mRNA from four genes (CEACAM4, LAMP1, PLA2G7, and PLAC8) involved in bacterial infection signaling. Studies have shown a specificity of 94% and a negative predictive value of 98.8% in ICU patients suspected of sepsis, with a threshold value above 4. These results have also been confirmed in elective esophageal surgery populations, demonstrating encouraging statistical performance.

Relevance to Acute Mesenteric Ischemia (AMI) AMI is a rare and difficult-to-diagnose condition with high diagnostic delays and mortality rates. Its initial presentation often mimics sepsis or septic shock, leading to the early administration of broad-spectrum empirical antibiotics due to fears of bacterial translocation or perforation. Although surgical guidelines encourage systemic antibiotic use, there is insufficient evidence for its routine application.

Study Objective While data on the SeptiCyte LAB test is available for cardiac and digestive surgeries, there is none for vascular surgery. This study aims to evaluate the SeptiCyte LAB test's ability to identify postoperative SIRS patients to reduce empirical antibiotic use while awaiting standard bacteriology results and to assess the impact of surgery on the SeptiCyte LAB test. We will study patients admitted to intensive care units pre- and post-open laparotomy for the treatment of embolic or thrombotic AMI.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Nancy, Lorraine, France, 54500
      • CHRU de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patient with suspected of confirmed acute mesenteric ischemia who required urgent surgery for revascularisation and/or intra-abdominal infection

Description

Inclusion Criteria:

• Patient aged over 18 years
• Affiliated to health assurance system
• Hospitalized in the ICU for confirmed mesenteric ischemia* for less than 24 hours with an indication for laparotomy
• Hospitalized in the ICU for confirmed mesenteric ischemia* who underwent laparotomy for revascularization or digestive resection less than 24 hours ago
• Intraoperative bacteriological samples and blood cultures performed within 24 hours of medical management

Exclusion Criteria:

• decline to participate
• no consent available

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; The control group will consist of adult patients undergoing open vascular surgery for the treatment of an aortic aneurysm. This procedure requires surgical aortic clamping of variable duration, which may lead to potential ischemic events in the digestive system	Device: Septicyte Lab Test pre operative; SeptiCyte® technology uses proprietary biomarker signatures to assess the response of a patient's immune system to infections. It provides a score which can be used to differentiate sepsis from systemic inflammatory response. Each included patient will received the Septicyte LAB test before and after surgery for acute mesenteric ischemia suspicion. The results will be compared to standard of care, retrospectively.; Device: Septicyte Lab Test post operative; SeptiCyte® technology uses proprietary biomarker signatures to assess the response of a patient's immune system to infections. It provides a score which can be used to differentiate sepsis from systemic inflammatory response. Each included patient will received the Septicyte LAB test before and after surgery for acute mesenteric ischemia suspicion. The results will be compared to standard of care, retrospectively.
Case; The "case" group consist of adult patients suffering from acute mesenteric ischemia who required urgent surgery	Device: Septicyte Lab Test pre operative; SeptiCyte® technology uses proprietary biomarker signatures to assess the response of a patient's immune system to infections. It provides a score which can be used to differentiate sepsis from systemic inflammatory response. Each included patient will received the Septicyte LAB test before and after surgery for acute mesenteric ischemia suspicion. The results will be compared to standard of care, retrospectively.; Device: Septicyte Lab Test post operative; SeptiCyte® technology uses proprietary biomarker signatures to assess the response of a patient's immune system to infections. It provides a score which can be used to differentiate sepsis from systemic inflammatory response. Each included patient will received the Septicyte LAB test before and after surgery for acute mesenteric ischemia suspicion. The results will be compared to standard of care, retrospectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of bacterial coinfection during acute mesenteric ischemia	Septicyte Lab test < 4 if there is no infection	Day 0 (pre operative)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of Septicyte Lab test to rule out the presence of intra-abdominal infection during acute mesenteric ischemia	Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the Septicyte Lab test	Day 0 (pre operative)
Diagnostic performance of PCT to rule out the presence of intra-abdominal infection during acute mesenteric ischemia	Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the PCT	Day 0 (pre operative)
Diagnostic performance of CRP to rule out the presence of intra-abdominal infection during acute mesenteric ischemia	Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the CRP	Day 0 (pre operative)
Change in Septicyte Lab test during the post-operative period to address the influence of surgery on the response of patient's immune system	Value of Septicyte Lab test	Day 1

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: sepsis; antimicrobial stewardship; intra-abdominal infection; acute mesenteric schema; septicyte; aortic vascular surgery; surgical aortic clamping
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Peritoneal Diseases; Ischemia; Inflammation; Intraabdominal Infections; Mesenteric Ischemia
• Other Study ID Numbers: NOVY_2024_PI_090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes