Université de Lorraine - CHRU de Nancy
Vandœuvre-lès-Nancy, Lorraine, 54500, France
NCT Number: NCT07005258
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.
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Notify Me18 year and older
All sexes
Observational
Vandœuvre-lès-Nancy, Lorraine, 54500, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day of the surgery
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the CandID PLUS PCR, using fungal culture as the reference standard.
Time frame: Day of the surgery
Sensitivity, specificity, PPV, and NPV of peritoneal 1,3-β-D-glucan compared with fungal culture; diagnostic performance comparison between CandID PLUS PCR and 1,3-β-D-glucan (including ROC curve analysis)
Time frame: Day 1 (surgery) to Day 28
Association between PCR Ct values and clinical severity (SOFA score) and ICU mortality
Central Hospital, Nancy, France
Other
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
Acronym: CANDIDIAG
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