Diagnosis of Lymphohistiocytic Hemophagocytosis in Intens... | NCT07343037

Studies
Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

NCT07343037

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Jan 15, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Hepatic Insufficiency
Cirrhosis, Liver

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 29, 2025Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Aug 29, 2026Estimated

First Submitted Date

Jan 6, 2026

First Submission Date that Met QC Criteria

Jan 6, 2026

First Posted Date

Jan 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2026

Last Update Posted Date

Jan 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Up to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonin HUGEROT, MD	Contact	33 3 88 12 79 24		antonin.hugerot@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Médecine intensive - Réanimation - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D048550	Hepatic Insufficiency
D008103	Liver Cirrhosis
D008107	Liver Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided