Early Identification of Candida in Intra-abdominal Candidiasis

NCT05264571 | Completed

• 1 other identifier: 2021PI051
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intra abdominal candidiasis; candida; diagnostic method; metabolic profile; virulence

Outcome Measures

Primary Outcomes (1)

• Detection (Yes/No) of the presence of Candida in the peritoneal fluid

  Detection by the calscreener : detection of metabolic activity \> 5 µW (according to SYMCEL recommendation)

  Day 1 - 3

Secondary Outcomes (1)

• Delay (in hours) of detection

  Day 1 - 3

Other Outcomes (4)

• Heat production (Joule)

  Day 1 - 3

• Candida morphology

  Day 1

• Candida growth

  Day 1

Study Arms (1)

critically ill adult patients with intra-abdominal infection

The ICCA study is an ancillary study of a non-interventional prospective cohort study (the pBDG2 study, NCT03997929) The pBDG 2 study has enrolled ICU patients with intra-abdominal infection requiring abdominal surgery. During the surgery, peritoneal fluid has been collected to identify the pathogens involved and guide anti-infective therapies. After the routine analyses, the remained peritoneal fluid was stored to create a biological collection. This biological collection, in which the content of bacterias and yeasts is known, will be analysed with the calscreener.

Diagnostic Test: calscreener; Other: Metabolic profile; Other: optical microscopy; Other: RTqPCR

Interventions

calscreener DIAGNOSTIC_TEST

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.

critically ill adult patients with intra-abdominal infection

Metabolic profile OTHER

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

critically ill adult patients with intra-abdominal infection

optical microscopy OTHER

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

critically ill adult patients with intra-abdominal infection

RTqPCR OTHER

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.

critically ill adult patients with intra-abdominal infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the present study will be used the clinical samples issued from the biological collection of peritoneal fluid issue from the pBDG2 study. The presence of Candida of each sample is known thanks to routine analysis. According to the ethic committee, only peritoneal fluid issued from patients from the centre "NANCY" will be investigated in the ICCA STUDY. The results obtained with the calscreener will be compared to those obtain by yeast culture to confirm the Candida detection irrespective and depending on the albicans and non-albicans species. Lastly the delay of detection with the calscreener will be compared to the growth delay of yeast culture

You may qualify if:

• adult
• Covered by health insurance
• Admitted in ICU with intra-abdominal infection requiring abdominal surgery or percutaneous drainage

You may not qualify if:

• Pregnant or lactating woman
• Patient deprived of liberty after administration of juridical decision
• Patient under psychiatric care

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• SYMCEL: collaborator

Study Sites (1)

Central Hospital

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

• Novy E, Esposito M, Birckener J, Germain A, Losser MR, Machouart MC, Guerci P. Reappraisal of intra-abdominal candidiasis: insights from peritoneal fluid analysis. Intensive Care Med Exp. 2023 Sep 30;11(1):67. doi: 10.1186/s40635-023-00552-0.

  PMID: 37776390 DERIVED

MeSH Terms

Conditions

Candidiasis, Invasive; Critical Illness; Torulopsis

Interventions

Metabolome; Microscopy

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metabolism; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: February 17, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 22, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)