An observational study in Intra-Abdominal Infection, Candida and Peritonitis Infectious, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Central Hospital, Nancy, France · Observational
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.
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's enrollment of 88 is below the median of 137 across 55 observational studies indexed under Peritonitis.
Browse Peritonitis studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
Compared within Peritonitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Intraabdominal Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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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Exclusion Criteria:
All patients have confirmed intra-abdominal candidiasis (positive Candida culture)
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.
Time frame: Day of the surgery
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)
Time frame: Day of the surgery
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
Time frame: Day 1 (surgery) to Day 28
Plan to share: No
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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