Hepatic InsufficiencySAMICUNCT07343037
Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care
An observational study of Hepatic Insufficiency and Cirrhosis, Liver, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Patients with hepatocellular insufficiency and/or cirrhosis are at risk of developing invasive fungal infections, particularly in critical care settings. In international recommendations, voriconazole is positioned as the first-line treatment for invasive aspergillosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Insufficiency, Cirrhosis, Liver
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2025to 29 Aug 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient admitted to the intensive care unit at Hautepierre Hospital, Strasbourg University Hospital, between January 1, 2014, and December 31, 2024
Who may be able to join
- Adult patient (≥18 years old)
- Patient admitted to the intensive care unit at Hautepierre Hospital, Strasbourg University Hospital, between January 1, 2014, and December 31, 2024
- At least 3 biological signs of HLH:
- ferritin > 2000 ng/mL
- triglycerides > 1.5 g/L
- at least one cytopenia (leukocytes ≤ 5000 G/L, platelets ≤ 110 G/L, hemoglobin ≤ 9.2 g/dL).
Who cannot join
- 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
Médecine intensive - Réanimation - CHU de Strasbourg - France
Strasbourg, 67091
Antonin HUGEROT, MD, 33 3 88 12 79 24, antonin.hugerot@chru-strasbourg.fr
Antonin HUGEROT, MD
About this study
Official title: Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care: Relevance of the Hscore and Search for the Best Diagnostic Markers
Patients with hepatocellular insufficiency and/or cirrhosis are at risk of developing invasive fungal infections, particularly in critical care settings.
In international recommendations, voriconazole is positioned as the first-line treatment for invasive aspergillosis. However, this molecule-and the azole class of antifungals-is associated with frequent hepatic toxicity. Available since 2018, isavuconazole appears to be better tolerated in patients without pre-existing liver dysfunction.
The aim of this study is to retrospectively evaluate the validity of the hscore in intensive care and resuscitation patients.
- Conditions
- Hepatic Insufficiency, Cirrhosis, Liver
- Keywords
- Hepatic Insufficiency, Cirrhosis, Liver, Lymphohistiocytic hemophagocytosis, Hepatocellular insufficiency, Invasive aspergillosis, Azole antifungals, Liver dysfunction.
- Medical subject headings
- Hepatic Insufficiency, Liver Cirrhosis, Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
hscore
The HScore adds up points assigned to 9 clinical, biological, and histological criteria:
The higher the total score, the greater the likelihood of HLH:
Possible total score: 0 to 337:
HScore: Probability of HLH:
< 90 points → Very low
- 130 points → ≈ 10-20% 168 points → high probability of HL
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start29 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completion29 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343037
- Sponsor's protocol ID
- 9818
- Acronym
- SAMICU
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care: Relevance of the Hscore and Search for the Best Diagnostic Markers
- ClinicalTrials.gov ID
- NCT07343037
- Acronym / sponsor ID
- SAMICU / 9818
- Conditions
- Hepatic Insufficiency, Cirrhosis, Liver
- Keywords
- Hepatic Insufficiency, Cirrhosis, Liver, Lymphohistiocytic hemophagocytosis, Hepatocellular insufficiency, Invasive aspergillosis, Azole antifungals, Liver dysfunction.
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- 29 Aug 2026 (estimated)
- First posted
- 15 Jan 2026 (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.
Patients with hepatocellular insufficiency and/or cirrhosis are at risk of developing invasive fungal infections, particularly in critical care settings.
In international recommendations, voriconazole is positioned as the first-line treatment for invasive aspergillosis. However, this molecule-and the azole class of antifungals-is associated with frequent hepatic toxicity. Available since 2018, isavuconazole appears to be better tolerated in patients without pre-existing liver dysfunction.
The aim of this study is to retrospectively evaluate the validity of the hscore in intensive care and resuscitation patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient admitted to the intensive care unit at Hautepierre Hospital, Strasbourg University Hospital, between January 1, 2014, and December 31, 2024
Key inclusion criteria (6 listed)
- Adult patient (≥18 years old)
- Patient admitted to the intensive care unit at Hautepierre Hospital, Strasbourg University Hospital, between January 1, 2014, and December 31, 2024
- At least 3 biological signs of HLH:
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hscore
Time frame: Up to 12 months
The HScore adds up points assigned to 9 clinical, biological, and histological criteria: The higher the total score, the greater the likelihood of HLH: Possible total score: 0 to 337: HScore: Probability of HLH: < 90 points → Very low * 130 points → ≈ 10-20% 168 points → high probability of HL
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 15 Jan 2026.
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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 Hepatic Insufficiency and Cirrhosis, Liver, run by University Hospital, Strasbourg, 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 6 inclusion and 1 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 15 Jan 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?
Contact Antonin HUGEROT, MD (33 3 88 12 79 24, antonin.hugerot@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hscore (time frame: Up to 12 months). 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 15 Jan 2026.