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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically ill patients with intra-abdominal candidiasis requiring abdominal surgery | All patients have confirmed intra-abdominal candidiasis (positive Candida culture) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the CandID PLUS PCR, using fungal culture as the reference standard. | Day of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the diagnostic performance of the CandID PLUS PCR with that of peritoneal 1,3-β-D-glucan | 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) | Day of the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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The pBDG2 study enrolled 199 ICU patients across four participating centers. Inclusion criteria were: adult ICU patients with suspected intra-abdominal infection likely due to Candida spp., requiring emergency abdominal surgery.
Among the enrolled patients, 88 were diagnosed with confirmed intra-abdominal candidiasis based on positive fungal culture.
Only these 88 patients will be eligible for inclusion in the CANDIDIAG study. This constitutes a post-hoc analysis of a predefined subpopulation from the pBDG2 cohort.
Participating centers included the University Hospitals of Nancy, Dijon, Strasbourg, and the Regional Hospital Center of Metz (CHR Metz)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université de Lorraine - CHRU de Nancy | Vandœuvre-lès-Nancy | Lorraine | 54500 | France |
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Peritoneal fluid samples
| 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 |
Association between PCR Ct values and clinical severity (SOFA score) and ICU mortality |
| Day 1 (surgery) to Day 28 |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| C536972 | Torulopsis |
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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