Intra-abdominal InfectionCANDIRISNCT07130799
Innate Immune Response Monitoring Via Monocyte HLA-DR in Severe Intra-abdominal Infections at Risk of Fungal Infection
An observational study of Intra-abdominal Infection and Critical Illness, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Intra-abdominal candidiasis (IAC) is a frequent and severe fungal infection in critically ill patients, often diagnosed late. Its pathophysiology remains unclear, particularly regarding why some patients develop invasive infection while others only show benign colonization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-abdominal Infection, Critical Illness, Post-Op Infection
- What is being tested?
- Immunomonitoring
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2025to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: This study will include adult patients (≥18 years) admitted to the intensive care unit (ICU) for severe intra-abdominal infections requiring urgent abdominal surgery. Participants must present at least one recognized risk factor for intra-abdominal candidiasis, such as recent abdominal surgery, gastrointestinal perforation, healthcare-associated infection, immunosuppression, septic shock, or recent exposure to broad-spectrum antibiotics.
Who may be able to join
- Adult patient (≥ 18 years old)
- Patient admitted to the ICU or intermediate care unit for a severe intra-abdominal infection requiring urgent abdominal surgery
- Presence of at least one risk factor for intra-abdominal candidiasis:
- Abdominal surgery within the last 7 days
- Supramesocolic gastrointestinal perforation
- Healthcare-associated intra-abdominal infection
Show all 12Show fewer
- Community-acquired intra-abdominal infection in an immunocompromised patient*
- Intra-abdominal infection complicated by septic shock
- Broad-spectrum antibiotic exposure within 72 hours prior to surgery
- And/or a Peritonitis Score ≥ 3 out of 4
- Patient affiliated with or benefiting from a national health insurance system
- Patient who has received full information about the clinical study
Who cannot join
- Radiologically guided drainage without surgery
- Infected acute pancreatitis
- Limitation or withdrawal of life-sustaining treatments
- Moribund patient with an expected life expectancy < 48 hours
- Woman of childbearing potential without effective contraception
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU de NANCY
Vandœuvre-lès-Nancy, 54500
Emmanuel NOVY, MD, PhD, +33 383157437, e.novy@chru-nancy.fr
Anne-Claire LUKASZEWICZ, MD,PhD
About this study
Official title: Evaluation of the Innate Immune Response Through Monocyte HLA-DR Monitoring During Severe Intra-abdominal Candidiasis in the Critically Ill Patients
Intra-abdominal candidiasis (IAC) is a frequent and severe fungal infection in critically ill patients, often diagnosed late. Its pathophysiology remains unclear, particularly regarding why some patients develop invasive infection while others only show benign colonization. A potential explanation lies in the state of innate immunity. Monocyte HLA-DR expression, a recognized marker of immune suppression in critical care, may be transiently but profoundly reduced in non-immunocompromised patients who go on to develop IAC. This observational study aims to evaluate whether patients with IAC have greater innate immune dysfunction-assessed by HLA-DR expression-compared to those with severe bacterial intra-abdominal infections. The goal is to better understand the immune mechanisms involved and improve early risk stratification for IAC.
- Conditions
- Intra-abdominal Infection, Critical Illness, Post-Op Infection, Immunization; Sepsis, Candida Sepsis
- Being tested
- Immunomonitoring
- Keywords
- intra-abdominal infection, intra-abdominal candidiasis, HLA-DR, immunomonitoring, monocyte, critically ill patients
- Medical subject headings
- Intraabdominal Infections, Critical Illness, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunomonitoringOther
To analyse monocyte HLA-DR expression (mHLA-DR) and CD4+ T lymphocyte count (CD4) in both group
| Study group | Role | What they receive |
|---|---|---|
| Intra-abdominal candidiasis | Intra-abdominal infection with intra-abdominal candidiasis based on the FUNDICU consensus Receives: Other: Immunomonitoring | |
| Bacterial Intra-abdominal infection | Intra-abdominal infection with a negative fungal culture Receives: Other: Immunomonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between percentage of Monocyte HLA-DR Expression and the Occurrence of Intra-abdominal Candidiasis
Assessment of the relationship between monocyte HLA-DR expression levels and the development of intra-abdominal candidiasis in critically ill patients with severe intra-abdominal infection.
Measured: Within 7 days after abdominal surgery
Secondary outcomes (4)
Change Over Time in Percentage of Monocytes Expressing HLA-DR Measured by Flow Cytometry in Patients With vs Without Intra-abdominal Candidiasis
Peripheral venous blood will be collected at Day 0 (within 6 hours after index surgery), Day 3, Day 5, and Day 7 post-surgery.
Monocyte HLA-DR expression will be quantified as the percentage of CD14+/CD16-/low monocytes positive for HLA-DR using standardized flow cytometry with anti-HLA-DR monoclonal antibody.
Results will be compared between patients with confirmed intra-abdominal candidiasis (peritoneal culture positive for Candida) and those with intra-abdominal infection without fungal involvement.
Primary analysis: between-group difference in change from baseline (Day 0) to Day 7 in percentage of HLA-DR+ monocytes
Measured: From Day 0 (surgery) to Day 7 post-surgery
Variation in Lymphocyte Subpopulations Based on Presence or Absence of Intra-abdominal Candidiasis
Analysis of the changes in lymphocyte subpopulations counts (CD4+ T cells, CD8+ T cells, NK cells, B cells) in patients with versus without intra-abdominal candidiasis
Measured: From Day 0 (surgery) to Day 7 post-surgery
Impact of Immune Dysfunction on In-Hospital Mortality
Evaluation of the correlation between low HLA-DR expression and in-hospital mortality
Measured: From surgery to Day 28
Impact of Immune Dysfunction on Source Control of Infection
Assessment of whether immune dysfunction (defined by a low expression level of HLA-DR) is associated with failure or delay in achieving effective surgical or medical source control of the intra-abdominal infection
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start14 Nov 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-abdominal InfectionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130799
- Sponsor's protocol ID
- 2024PI208
- Acronym
- CANDIRIS
- Status last verified
- Nov 2025
- First submitted
- 24 Jul 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Innate Immune Response Through Monocyte HLA-DR Monitoring During Severe Intra-abdominal Candidiasis in the Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07130799
- Acronym / sponsor ID
- CANDIRIS / 2024PI208
- Conditions
- Intra-abdominal Infection, Critical Illness, Post-Op Infection, Immunization; Sepsis, Candida Sepsis
- Keywords
- intra-abdominal infection, intra-abdominal candidiasis, HLA-DR, immunomonitoring, monocyte, critically ill patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 Aug 2025 (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 (IAC) is a frequent and severe fungal infection in critically ill patients, often diagnosed late. Its pathophysiology remains unclear, particularly regarding why some patients develop invasive infection while others only show benign colonization. A potential explanation lies in the state of innate immunity. Monocyte HLA-DR expression, a recognized marker of immune suppression in critical care, may be transiently but profoundly reduced in non-immunocompromised patients who go on to develop IAC. This observational study aims to evaluate whether patients with IAC have greater innate immune dysfunction-assessed by HLA-DR expression-compared to those with severe bacterial intra-abdominal infections. The goal is to better understand the immune mechanisms involved and improve early risk stratification for IAC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-abdominal candidiasis | – | Other: ImmunomonitoringIntra-abdominal infection with intra-abdominal candidiasis based on the FUNDICU consensus |
| Bacterial Intra-abdominal infection | – | Other: ImmunomonitoringIntra-abdominal infection with a negative fungal culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will include adult patients (≥18 years) admitted to the intensive care unit (ICU) for severe intra-abdominal infections requiring urgent abdominal surgery. Participants must present at least one recognized risk factor for intra-abdominal candidiasis, such as recent abdominal surgery, gastrointestinal perforation, healthcare-associated infection, immunosuppression, septic shock, or recent exposure to broad-spectrum antibiotics.
Key inclusion criteria (12 listed)
- Adult patient (≥ 18 years old)
- Patient admitted to the ICU or intermediate care unit for a severe intra-abdominal infection requiring urgent abdominal surgery
- Presence of at least one risk factor for intra-abdominal candidiasis:
- And/or a Peritonitis Score ≥ 3 out of 4
- Patient affiliated with or benefiting from a national health insurance system
Key exclusion criteria (6 listed)
- Radiologically guided drainage without surgery
- Infected acute pancreatitis
- Limitation or withdrawal of life-sustaining treatments
- Moribund patient with an expected life expectancy < 48 hours
- Woman of childbearing potential without effective contraception
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 |
|---|---|---|
| ImmunomonitoringTo analyse monocyte HLA-DR expression (mHLA-DR) and CD4+ T lymphocyte count (CD4) in both group | Other | Bacterial Intra-abdominal infection, Intra-abdominal candidiasis |
Primary outcome
Correlation Between percentage of Monocyte HLA-DR Expression and the Occurrence of Intra-abdominal Candidiasis
Time frame: Within 7 days after abdominal surgery
Assessment of the relationship between monocyte HLA-DR expression levels and the development of intra-abdominal candidiasis in critically ill patients with severe intra-abdominal infection.
4 secondary outcomes
Change Over Time in Percentage of Monocytes Expressing HLA-DR Measured by Flow Cytometry in Patients With vs Without Intra-abdominal Candidiasis
Time frame: From Day 0 (surgery) to Day 7 post-surgery
Variation in Lymphocyte Subpopulations Based on Presence or Absence of Intra-abdominal Candidiasis
Time frame: From Day 0 (surgery) to Day 7 post-surgery
Impact of Immune Dysfunction on In-Hospital Mortality
Time frame: From surgery to Day 28
Impact of Immune Dysfunction on Source Control of Infection
Time frame: Up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Intra-abdominal Infection and Critical Illness, 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 12 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between percentage of Monocyte HLA-DR Expression and the Occurrence of Intra-abdominal Candidiasis (time frame: Within 7 days after abdominal surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.