Liver Cirrhosis Patients With Invasive Pulmonary Aspergillosis: in Depth Understanding Clinical Host Risk Factors

NCT ID: NCT07238114

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-07-31

Brief Summary

Invasive pulmonary aspergillosis (IPA) is a life-threatening fungal infection of the respiratory system, caused by a specific fungus called Aspergillus species. It is already known that patients with a weakened immune system are at higher risk of developing this disease. Recently, it has also been shown that patients with viral pneumonia (such as influenza or COVID-19) and patients with liver cirrhosis who are admitted to the intensive care unit are also vulnerable to this infection.

This study aims to better define the epidemiology, clinical risk factors, outcomes, and treatment of IPA in ACLF patients admitted to the ICU. By combining clinical data with histological findings from autopsies, the study seeks to improve diagnostic accuracy, risk prediction, and timely initiation of antifungal therapy.

Conditions

Liver Cirrhosis; Viral Pneumonia; Fungal Infection; Invasive Pulmonary Aspergillosis; Intensive Care Medicine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ICU patients with liver cirrhosis and IPA

The study population includes patients with confirmed or suspected liver cirrhosis who were admitted to the Medical ICU of UZ Leuven.

Invasive pulmonary aspergillosis (IPA) is a life-threatening fungal infection, historically seen in severely immunocompromised patients. In recent years, it has also been increasingly recognized in ICU patients without classic immunosuppression, including those with viral pneumonia (e.g., influenza, COVID-19) and those with liver cirrhosis and acute-on-chronic liver failure (ACLF).

No interventions assigned to this group

ICU patient with liver cirrhosis without IPA

The study population consists of patients with known or suspected liver cirrhosis who were admitted to the Medical ICU of UZ Leuven.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• All adults (≥ 18 years old)
• Acute-on-Chronic liver failure
• Respiratory distress
• Admission to the Medical Intensive Care Unit of University Hospitals of Leuven

Exclusion Criteria

• Patients < 18 years
• Respiratory distress not being the primary reason for ICU admission
• Patients with influenza or COVID-19
• Recent history of invasive pulmonary aspergilosis and/or invasive candidiasis (<1 month before ICU admission) and/or active treatment for IPA and/or invasive candidiasis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joost Wauters, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

IN-BE-131-7804

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S68965

Identifier Type: -

Identifier Source: org_study_id