Recruiting

NCT Number: NCT07343037

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hepatic Insufficiency Cirrhosis, Liver Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Médecine intensive - Réanimation - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Antoine CHANZY, MD

SUB_INVESTIGATOR

Antonin HUGEROT, MD

CONTACT

[email protected]

33 3 88 12 79 24

Antonin HUGEROT, MD

PRINCIPAL_INVESTIGATOR

Vincent CASTELAIN, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

Refusal to participate in the study

Treatment and study plan

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Antonin HUGEROT, MD

CONTACT

[email protected]

33 3 88 12 79 24

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care: Relevance of the Hscore and Search for the Best Diagnostic Markers

Acronym: SAMICU

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 15, 2026
Registry last updated: Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting