Clinical trial NCT05264571: Early Identification of Candida in Intra-abdominal Candidiasis
Official title: The ICCA Study (Early Identification of Candida in Intra-abdominal CAndidiasis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candida Sepsis
Candidiasis, Invasive
Peritonitis Infectious
Critically Ill
Keywords: intra abdominal candidiasis
candida
diagnostic method
metabolic profile
virulence
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: SYMCEL
First posted: 2022-03-03
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Detailed description: The high mortality rate of patients with intra-abdominal candidiasis infection is partly related to delay in anti-fungal treatment. The gold standard method for Candida detection remains the yeast culture on mycological media which suffers from a delayed response time (up to 5 days).

Consequently, in the routine practice, the decision to start an anti-fungal treatment is based on predictive scores such as the Peritonitis score. Whatever the score, they all suffer from a lack of sensitivity and specificity and could expose ICU patients to delayed treatment with negative impact on mortality. Once introduced and before the availability of the result of the culture, the anti-fungal can be stopped based on two serum measures of 1,3 beta D Glucan \< 80 pg/ml. This strategy allows anti-fungal spare. Therefore, there is a room for improvement regarding early Candida detection and identification for the right choice of anti-fungal.

The calscreener (SYMCEL®) is a new diagnostic tool to rapidly identify the presence of pathogens in biological samples based on micrometabolic activity detection. The metabolic activity anticipates the future positive culture. To date, most of the experiments with the calscreenerTM concern bacteria. During the development phase, some experiments have been performed with Candida, mostly in vitro. Data of feasibility with clinical samples such as the peritoneal fluid are lacking. Besides, there is currently no library regarding the metabolic profile of Candida, in both albicans and non-albicans species. All in all, its routine use is currently impossible.

First results (unpublished data from our team) of metabolic activity detection in peritoneal fluid with known presence of Candida showed a time detection \<1 hour. We aim to confirm these promising results using biological samples collected in an ongoing cohort study. We first need to describe the metabolic activity curves of different Candida species in order to constitute a library.

The heat production of each peritoneal fluid will be measured, and then compared considering the presence or absence of bacteria. Then, to explain the metabolic activity, a phenotypic evaluation of candida (growth and yeast-to-hyphae transition) and molecular evaluation (level of expression of virulence gene) will be performed.

Eligibility criteria: The criteria belong to the pBDG2 study (Peritoneal 1.3-ß-D-glucan for the Diagnosis of Intra-abdominal Candidiasis in Critically Ill Patients).

Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Detection (Yes/No) of the presence of Candida in the peritoneal fluid
timeFrame: Day 1 - 3
Secondary outcomes:
measure: Delay (in hours) of detection
timeFrame: Day 1 - 3
Other outcomes:
measure: Heat production (Joule)
timeFrame: Day 1 - 3
measure: Candida morphology
timeFrame: Day 1
measure: Candida growth
timeFrame: Day 1
measure: Candida virulence gene expression
timeFrame: Day 1
Locations:
city: Vandoeuvre les Nancy
country: France
facility: Central Hospital
Study officials:
References: