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

NCT07238114 | Active Not Recruiting

• 2 other identifiers: S68965IN-BE-131-7804
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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; Intensive Care Medicine; Invasive Pulmonary Aspergillosis

Outcome Measures

Primary Outcomes (2)

• IPA incidence

  The incidence of proven invasive pulmonary aspergillosis (IPA) in critically ill cirrhotic patients will be assessed. Routinely used biochemical and microbiological tests (such as galactomannan and Aspergillus PCR) will be performed on blood and BAL samples stored in the biobank to identify affected patients.

  From the date of ICU admission until ICU discharge, approximately 7 days

• Identifying whether ACLF is an independent risk factor for IPA in EORTC-negative critically ill patients

  The occurrence of IPA will be compared between an ACLF EORTC-negative cohort and a non-ACLF cohort

  From the date of ICU admission until ICU discharge, approximately 7 days

Secondary Outcomes (11)

• Clinical characteristics of IPA

  From the date of ICU admission until ICU discharge, approximately 7 days

• Radiological characteristics of IPA

  From the date of ICU admission until ICU discharge, approximately 7 days

• Mycological characteristics of IPA

  From the date of ICU admission until ICU discharge, approximately 7 days

• Impact of IPA on length of ICU stay

  From the date of ICU admission until ICU discharge, approximately 7 days

• Impact of IPA on length of hospital stay

  From the date of ICU admission until hospital discharge, approximately 36 days

Study Arms (2)

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).

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• All adults (≥ 18 years old)
• Chronic liver disease
• Admission to the Medical Intensive Care Unit of University Hospitals of Leuven

You may not qualify if:

• Patients \< 18 years
• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Gilead Sciences: collaborator

Study Sites (1)

UZ Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Liver Cirrhosis; Pneumonia, Viral; Mycoses; Invasive Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections and Mycoses; Pulmonary Aspergillosis; Aspergillosis; Invasive Fungal Infections; Lung Diseases, Fungal

Study Officials

• Joost Wauters, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: November 20, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

BE (1)