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

March 3, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IPA incidence
Time Frame: From the date of ICU admission until ICU discharge, approximately 7 days
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
Time Frame: From the date of ICU admission until ICU discharge, approximately 7 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical characteristics of IPA
Time Frame: From the date of ICU admission until ICU discharge, approximately 7 days
Baseline characteristics, organ failures, organ support, outcome parameters
From the date of ICU admission until ICU discharge, approximately 7 days
Radiological characteristics of IPA
Time Frame: From the date of ICU admission until ICU discharge, approximately 7 days
Chest CT
From the date of ICU admission until ICU discharge, approximately 7 days
Mycological characteristics of IPA
Time Frame: From the date of ICU admission until ICU discharge, approximately 7 days
Galactomannan testing, Aspergillus PCR, mycological culture
From the date of ICU admission until ICU discharge, approximately 7 days
Impact of IPA on liver transplant eligibility
Time Frame: From the date of ICU admission until ICU discharge, approximately 7 days
From the date of ICU admission until ICU discharge, approximately 7 days
Histological characteristics of IPA using tissue staining
Time Frame: Through study completion, an average of 3 years
Histological characteristics of IPA in critically ill cirrhotic patients will be analyzed. Additional histological staining (e.g., Grocott stain) will be performed to detect fungal hyphae.
Through study completion, an average of 3 years
Histological characteristics of IPA using microbiological testing
Time Frame: Through study completion, an average of 3 years
Histological characteristics of IPA in critically ill cirrhotic patients will be analyzed. Additional microbiological testing (e.g., Aspergillus PCR) will be performed to detect fungal hyphae.
Through study completion, an average of 3 years
Correlation of pre-mortem data with post-mortem lung tissue findings
Time Frame: Through study completion, an average of 3 years
Through study completion, an average of 3 years
Impact of IPA on length of ICU stay
Time Frame: From the date of ICU admission until ICU discharge, approximately 7 days
From the date of ICU admission until ICU discharge, approximately 7 days
Impact of IPA on length of hospital stay
Time Frame: From the date of ICU admission until hospital discharge, approximately 36 days
From the date of ICU admission until hospital discharge, approximately 36 days
Impact of IPA on mortality
Time Frame: From ICU admission until 90 days post-admission
From ICU admission until 90 days post-admission
Impact of IPA on liver transplant delisting
Time Frame: From the date of ICU admission until ICU discharge, approximately 7 days
From the date of ICU admission until ICU discharge, approximately 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Joost Wauters, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

September 9, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S68965
  • IN-BE-131-7804 (Other Grant/Funding Number: Gilead Sciences)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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