Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT07005258
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.
Study:
NCT07005258
Study Brief:
Protocol Section:
NCT07005258