Innate Immune Response Monitoring Via Monocyte HLA-DR in Severe Intra-abdominal Infections at Ris… (NCT07130799) | Clinical Trial Compass
RecruitingNot Applicable
Innate Immune Response Monitoring Via Monocyte HLA-DR in Severe Intra-abdominal Infections at Risk of Fungal Infection
France100 participantsStarted 2025-11-14
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation Between percentage of Monocyte HLA-DR Expression and the Occurrence of Intra-abdominal Candidiasis