Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624618
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-30
Brief Title:
Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rapid Molecular Detection of Sepsis in Whole Blood
Status:
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:
RADOS
Brief Summary:
Rapid diagnosis of sepsis is crucial for treatment and survival Currently blood culture takes 48 hours-5 days to complete After starting antimicrobial treatment blood culture results are not reliable As a result empirical broad spectrum antimicrobial therapy is mostly used This implies possible antimicrobial over- or under treatment which is associated with increased antimicrobial resistance development Early identification of the causative pathogen of sepsis will therefore have a major impact on the adequate treatment and reduction of high mortality rates To date there is not a single molecular diagnostic test available on the market to detect all putative causative bacterial pathogens of sepsis In this study the investigators will develop and validate a completely new molecular sepsis approach based on pathogen DNA detection as an alternative to culture
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