Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456151
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-04
Brief Title:
Invasive Candidiasis in Critical Care
Sponsor:
University Hospital Ostrava
Organization:
University Hospital Ostrava
Study Overview
Official Title:
Invasive Candidiasis in Critical Care
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The combination of acute phase marker monitoring and the T2Candida assay name of the test will represent an acceleration of the identification of the causative agent of mycotic infection a significant improvement in the specificity and positive predictive value of this strategy in the diagnosis of invasive candidiasis and candidemia in ICU patients thereby improving the clinical condition of patients and reducing the cost of specific antifungal therapy
Detailed Description:
Speed of response in the treatment of sepsis is crucial for the patient The time from the collection of a positive haemoculture to the identification of the causative agent of sepsis is around 2 days therefore physicians in intensive care units deploy combined empiric antibiotic and antifungal therapy immediately when acute phase markers such as procalcitonin interleukin-6 Presepsin C-reactive protein are elevated A new acute phase marker is lipopolysaccharide-binding protein which together with Presepsin appears to be a suitable marker to distinguish invasive candida infections from bacterial infections But its kinetics needs to be further analyzed
At the same time the causative agent of sepsis G-G bacteria or yeast must be identified as soon as possible Haemoculture and culture of the established drain is the gold standard but the disadvantage is the low sensitivity and the time delay to obtain the result It is therefore advisable to combine haemoculture with molecular biology-based tests that can identify the causative organism within hours Conversely the disadvantage of these tests is that they identify only the most common sepsis pathogens and do not determine susceptibility to antibiotics and antifungals but the advantage is that with prophylaxis in place these tests are often positive when haemoculture is negative The T2Candida test can detect Candida albicans Candida tropicalis Candida glabrata Candida krusei and Candida parapsilosis which are the more common causative agents of mycotic bloodstream infections
At the same time the causative agent of sepsis G-G bacteria or yeast must be identified as soon as possible Haemoculture and culture of the established drain is the gold standard but the disadvantage is the low sensitivity and the time delay to obtain the result It is therefore advisable to combine haemoculture with molecular biology-based tests that can identify the causative organism within hours Conversely the disadvantage of these tests is that they identify only the most common sepsis pathogens and do not determine susceptibility to antibiotics and antifungals but the advantage is that with prophylaxis in place these tests are often positive when haemoculture is negative The T2Candida test can detect Candida albicans Candida tropicalis Candida glabrata Candida krusei and Candida parapsilosis which are the more common causative agents of mycotic bloodstream infections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03RVO-FNOs2024 | OTHER_GRANT | None | None |
| SGS06LF2024 | OTHER_GRANT | Faculty of Medicine University of Ostrava | None |