NCT05264571: ICCA

Early Identification of Candida in Intra-abdominal Candidiasis

Completed Last updated 17 July 2023

What this trial tests

trial testing calscreener in Candida Sepsis in 40 participants. Completed in 22 June 2023.

Timeline

17 February 2022

Primary endpoint
30 June 2022

22 June 2023

Quick facts

Lead sponsor	Central Hospital, Nancy, France
Status	Completed
Study type	OBSERVATIONAL
Enrollment	40
Start date	17 February 2022
Primary completion	30 June 2022
Estimated completion	22 June 2023
Sites	1 location across France

Drugs / interventions tested

• calscreener
• Metabolic profile — full drug profile →
• optical microscopy
• RTqPCR

Conditions studied

• Candida Sepsis — all drugs for Candida Sepsis →
• Candidiasis, Invasive — all drugs for Candidiasis, Invasive →
• Peritonitis Infectious — all drugs for Peritonitis Infectious →
• Critically Ill — all drugs for Critically Ill →

Sponsor

Central Hospital, Nancy, France

Who can join

Eligibility, any sex, with Candida Sepsis or Candidiasis, Invasive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intra-abdominal candidiasis remains the first origin of invasive candidiasis in critically ill patients with a mortality up to 60%. This high mortality is partly related to delay of anti-fungal treatment administration. According to experts in the field, new diagnostic methods to rapidly detect Candida in intra-abdominal infections is mandatory because the current strategies suffer from a lack of both sensitivity and specificity.

The calscreener (SYMCEL®) is a new diagnostic tool to rapidly identify the presence of pathogens in biological samples based on micrometabolic activity detection. This technology also allows to measure the metabolic activity of pathogens.

The ICCA project will test the feasibility, the accuracy and the diagnostic performance of the calscreener on an existing biological collection of peritoneal fluid. This collection came from a cohort of critically ill patients with intra-abdominal infection which required abdominal surgery. Intra-abdominal infections consist of bacterial peritonitis and intra-abdominal candidiasis. The presence of pathogens (bacteria and yeast) is already known, the peritoneal fluid being stored after routine analysis (bacteriology / mycology).

In addition to the detection / identification of yeast will be investigated in this project, the cal screener will be used to evaluate the metabolic profile of Candida albicans in the peritoneal fluid, alone and with bacteria. This objective aims to evaluate the virulence of Candida in the peritoneal fluid from a metabolic perspective. The results will be compared to phenotypic and molecular evaluation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reappraisal of intra-abdominal candidiasis: insights from peritoneal fluid analysis.
   Novy E, Esposito M, Birckener J, Germain A, et al · · 2023 · cited 3× · PMID 37776390 · DOI 10.1186/s40635-023-00552-0