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

NCT07005258 | Completed

• 1 other identifier: 2025PI060
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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

Keywords

intra-abdominal candidiasis; secondary peritonitis; candida; PCR; molecular diagnostic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• To compare the diagnostic performance of the CandID PLUS PCR with that of peritoneal 1,3-β-D-glucan

  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

  Day 1 (surgery) to Day 28

Study Arms (1)

Critically ill patients with intra-abdominal candidiasis requiring abdominal surgery

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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

You may not qualify if:

• Declined to participate
• intra-abdominal candidiasis caused by other candida species

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Université de Lorraine - CHRU de Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peritoneal fluid samples

MeSH Terms

Conditions

Intraabdominal Infections; Torulopsis; Peritonitis

Condition Hierarchy (Ancestors)

Infections; Peritoneal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 5, 2025
• Study Start: April 17, 2025
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)