Early Identification of Candida in Intra-abdominal Candidiasis

NCT05264571 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-07-17

No results posted yet for this study

Summary

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.

Conditions

  • Candida Sepsis
  • Candidiasis, Invasive
  • Peritonitis Infectious
  • Critically Ill

Interventions

DIAGNOSTIC_TEST

calscreener

The calscreener (SYMCEL®) is a new diagnostic tool to rapidly identify the presence of pathogens in biological samples based on micrometabolic activity detection. All living cells produce heat by the chemical and physical processes of life; by monitoring the heat flow over time (J/s, W) a significant amount of information can be obtained regarding the biological system.

OTHER

Metabolic profile

The cal screener allows the measure of metabolic activity of pathogens directly from a sample (here, the peritoneal fluid). The heat production will be compared between peritoneal fluid, with or without addition of bacteria

OTHER

optical microscopy

To explain the metabolic activity, growth and yeast-to-hyphae transition will be analysed using optical microscopy and conventional culture

OTHER

RTqPCR

To explain the metabolic activity, level of expression of 5 Candida albicans virulence genes (UME6, ALS3, SFL2, HWP1 and ECE1) will be address and compared between peritoneal fluid.

Sponsors & Collaborators

  • SYMCEL

    collaborator UNKNOWN
  • Central Hospital, Nancy, France

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2022-06-30
Completion
2023-06-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05264571 on ClinicalTrials.gov