Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507423
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Performance of the SeptiCyte LAB Test for Antibiotic Stewardship in Mesenteric Ischemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study to Evaluate the Performance of the SeptiCyte LAB Test for Antibiotic Stewardship in Mesenteric Ischemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPASM
Brief Summary:
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
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 988 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 tests 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
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 988 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 tests 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None