Candida, Critically Ill Intensive Care Unit Patients, Intra-Abdominal Infection, Molecular Diagnostic, Peritonitis Infectious
Conditions
Keywords
intra-abdominal candidiasis, secondary peritonitis, candida, PCR, molecular diagnostic
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.
Interventions
None listed
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult critically ill patient * with confirmed intra-abdominal candidiasis (culture positive with Candida albicans, glabrata, parapsilosis, tropicalis, krusei, and dubliniensis) * enrolled in the pBDG2 study (NCT 03997929) * intra-abdominal candidiasis documented at
Exclusion criteria
* Declined to participate * intra-abdominal candidiasis caused by other candida species
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the diagnostic performance of the CandID PLUS PCR for the detection of Candida albicans, glabrata, parapsilosis, tropicalis, krusei, and dubliniensis in peritoneal fluid of ICU patients with intra-abdominal candidiasis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the diagnostic performance of the CandID PLUS PCR with that of peritoneal 1,3-β-D-glucan | 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) |
| To explore the association between PCR cycle threshold (Ct) values (as a proxy for fungal load) and clinical parameters, including SOFA score and ICU mortality | Day 1 (surgery) to Day 28 | Association between PCR Ct values and clinical severity (SOFA score) and ICU mortality |
Countries
France
Outcome results
None listed