Diagnostic Performance of the CandID PLUS PCR for the Diagnosis of Intra-abdominal Candidiasis in Critically Ill Patients

NCT ID: NCT07005258

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-17
• Study Completion Date: 2025-04-17

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.

Conditions

Intra-Abdominal Infection; Candida; Peritonitis Infectious; Molecular Diagnostic; Critically Ill Intensive Care Unit Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Critically ill patients with intra-abdominal candidiasis requiring abdominal surgery

All patients have confirmed intra-abdominal candidiasis (positive Candida culture)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Université de Lorraine - CHRU de Nancy

Vandœuvre-lès-Nancy, Lorraine, France

Countries

France

Other Identifiers

2025PI060

Identifier Type: -

Identifier Source: org_study_id