Candida SepsisICCANCT05264571
Early Identification of Candida in Intra-abdominal Candidiasis
An observational study of Candida Sepsis and Candidiasis, Invasive, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Candida Sepsis, Candidiasis, Invasive, Peritonitis Infectious
- What is being tested?
- calscreener, Metabolic profile and optical microscopy
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2022to 22 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- adult
- Covered by health insurance
- Admitted in ICU with intra-abdominal infection requiring abdominal surgery or percutaneous drainage
Who cannot join
- Pregnant or lactating woman
- Patient deprived of liberty after administration of juridical decision
- Patient under psychiatric care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The ICCA Study (Early Identification of Candida in Intra-abdominal CAndidiasis)
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.
Read more
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.
Read the 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.
- Being tested
- calscreener, Metabolic profile, optical microscopy, RTqPCR
- Keywords
- intra abdominal candidiasis, candida, diagnostic method, metabolic profile, virulence
- Medical subject headings
- Candidiasis, Invasive, Critical Illness, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calscreenerDiagnostic 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.
Metabolic profileOther
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
optical microscopyOther
To explain the metabolic activity, growth and yeast-to-hyphae transition will be analysed using optical microscopy and conventional culture
RTqPCROther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: calscreener; Other: Metabolic profile; Other: optical microscopy; Other: RTqPCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1 - 3
Secondary outcomes (1)
Delay (in hours) of detection
Delay (in hours) from the start of calscreener analysis to first detection of heat flow > 5 µW
Measured: Day 1 - 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start17 Feb 2022
- Primary completion30 Jun 2022
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Candida SepsisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- SYMCEL
- Responsible party
- Principal investigator, NOVY Emmanuel, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264571
- Sponsor's protocol ID
- 2021PI051
- Acronym
- ICCA
- Status last verified
- Jul 2023
- First submitted
- 22 Feb 2022
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37776390
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ICCA Study (Early Identification of Candida in Intra-abdominal CAndidiasis)
- ClinicalTrials.gov ID
- NCT05264571
- Acronym / sponsor ID
- ICCA / 2021PI051
- Keywords
- intra abdominal candidiasis, candida, diagnostic method, metabolic profile, virulence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- SYMCEL
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill adult patients with intra-abdominal infection | – | Diagnostic Test: calscreener, Other: Metabolic profile, Other: optical microscopy, Other: RTqPCRThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- adult
- Covered by health insurance
- Admitted in ICU with intra-abdominal infection requiring abdominal surgery or percutaneous drainage
Key exclusion criteria (3 listed)
- Pregnant or lactating woman
- Patient deprived of liberty after administration of juridical decision
- Patient under psychiatric care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calscreenerThe 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. | Diagnostic test | critically ill adult patients with intra-abdominal infection |
| Metabolic profileThe 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 | critically ill adult patients with intra-abdominal infection |
| optical microscopyTo explain the metabolic activity, growth and yeast-to-hyphae transition will be analysed using optical microscopy and conventional culture | Other | critically ill adult patients with intra-abdominal infection |
| RTqPCRTo 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. | Other | critically ill adult patients with intra-abdominal infection |
Primary outcome
Detection (Yes/No) of the presence of Candida in the peritoneal fluid
Time frame: Day 1 - 3
Detection by the calscreener : detection of metabolic activity > 5 µW (according to SYMCEL recommendation)
1 secondary outcome
Delay (in hours) of detection
Time frame: Day 1 - 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Derived from this study: PubMed 37776390Novy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candida Sepsis and Candidiasis, Invasive, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection (Yes/No) of the presence of Candida in the peritoneal fluid (time frame: Day 1 - 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05264571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.