Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-03 @ 6:36 AM
Study NCT ID:
NCT07005258
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Performance of the CandID PLUS PCR for the Diagnosis of Intra-abdominal Candidiasis in Critically Ill Patients
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Evaluation of the Diagnostic Performance of the CandID PLUS PCR for the Detection of Candida Spp. in Peritoneal Fluid of Critically Ill Patients With Suspected Intra-abdominal Candidiasis
Status:
COMPLETED
Status Verified Date:
2025-04
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:
CANDIDIAG
Brief Summary:
Invasive candidiasis are the most common form of fungal infection in critically ill patients, particularly intra-abdominal candidiasis (IAC), which is associated with high morbidity and mortality. The current diagnostic gold standard relies on conventional fungal culture, which has a long turnaround time and may delay targeted antifungal therapy. Non-culture-based assays such as 1,3-β-D-glucan lack specificity for early and definitive diagnosis. Molecular diagnostics, including PCR, offer faster and more specific detection, but their clinical use remains limited.
The CandID PLUS PCR assay targets major Candida species and has not yet been evaluated on peritoneal fluid.
The CANDIDIAG study aims to assess the feasibility and diagnostic performance of the CandID PLUS PCR in detecting Candida spp. in peritoneal fluid from ICU patients with suspected IAC.
This study constitutes a post-hoc analysis of the pBDG2 study (Prospective evaluation of the peritoneal 1.3 Beta-D-glucan for the diagnosis of intra-abdominal candidiasis in the critically ill patients) registered with the number NCT 03997929). Therefore, all patients have been already recruited. For the CANDIDIAG study, we will use the biological collection of peritoneal fluid issue from the pBDG2 study. All patients with confirmed intra-abdominal candidiasis are identified. We will test de CandID PCR, retrospectively, on their peritoneal fluid and compared the results with the fungal culture.
The CandID PLUS PCR assay targets major Candida species and has not yet been evaluated on peritoneal fluid.
The CANDIDIAG study aims to assess the feasibility and diagnostic performance of the CandID PLUS PCR in detecting Candida spp. in peritoneal fluid from ICU patients with suspected IAC.
This study constitutes a post-hoc analysis of the pBDG2 study (Prospective evaluation of the peritoneal 1.3 Beta-D-glucan for the diagnosis of intra-abdominal candidiasis in the critically ill patients) registered with the number NCT 03997929). Therefore, all patients have been already recruited. For the CANDIDIAG study, we will use the biological collection of peritoneal fluid issue from the pBDG2 study. All patients with confirmed intra-abdominal candidiasis are identified. We will test de CandID PCR, retrospectively, on their peritoneal fluid and compared the results with the fungal culture.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: