Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633770
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Role of Presepsin as a Novel Biomarker in Diagnosis of Neonatal Sepsis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Role of Presepsin as a Novel Biomarker in Diagnosis of Neonatal Sepsis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
-Introduction Sepsis is a clinical syndrome that results from a deregulated inflammatory response to an infection it is life-threatening entity causing millions of deaths worldwide with variable clinical manifestations and poses difficulty in diagnosis and treatment Early recognition of sepsis not only helps in the optimization of treatment but also improves the overall outcome
Neonatal sepsis is generally considered a spectrum of disorders that result from infection by bacteria viruses fungi or parasites or the toxic products of these It is characterized by nonspecific signs and symptoms so it is a conundrum of diagnostic and therapeutic challenges The proof of infection is seldom encountered in practice as the confirmatory microbial culture yield can be as low as 25-30 Hence clinicians often depend on commonly available biomarkers such as C-reactive Protein CRP and procalcitonin PCT for diagnosing infection Even though helpful these markers are fraught with errors and limitations There is an exigent need for a novel biomarker that can serve as a clear distinguisher of sepsis from other non-septic inflammatory conditions The role of presepsin as a biomarker of sepsis in children is still a matter of scientific inquiry
CD14 is a co-receptor present on the surface of the monocytemacrophage It is a member of the Toll-like receptors TLRswith an ability to identify groups of ligands of both gram-positive and gram-negative pathogens CD14 exists in two forms namely membrane-bound mCD14 and a soluble form sCD14 The sCD14 has different subtypes that get released in circulation and acted upon by proteases and cathepsin D The N terminal fragment of the sCD14-ST subtype is called presepsin
Neonatal sepsis is generally considered a spectrum of disorders that result from infection by bacteria viruses fungi or parasites or the toxic products of these It is characterized by nonspecific signs and symptoms so it is a conundrum of diagnostic and therapeutic challenges The proof of infection is seldom encountered in practice as the confirmatory microbial culture yield can be as low as 25-30 Hence clinicians often depend on commonly available biomarkers such as C-reactive Protein CRP and procalcitonin PCT for diagnosing infection Even though helpful these markers are fraught with errors and limitations There is an exigent need for a novel biomarker that can serve as a clear distinguisher of sepsis from other non-septic inflammatory conditions The role of presepsin as a biomarker of sepsis in children is still a matter of scientific inquiry
CD14 is a co-receptor present on the surface of the monocytemacrophage It is a member of the Toll-like receptors TLRswith an ability to identify groups of ligands of both gram-positive and gram-negative pathogens CD14 exists in two forms namely membrane-bound mCD14 and a soluble form sCD14 The sCD14 has different subtypes that get released in circulation and acted upon by proteases and cathepsin D The N terminal fragment of the sCD14-ST subtype is called presepsin
Detailed Description:
None
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