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NCT Number: NCT07238114

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

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.

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Key information

Conditions

Liver Cirrhosis Aspergillosis Bacterial Infections and Mycoses Digestive System Diseases Fibrosis Fungal Infection Infections Intensive Care Medicine Invasive Fungal Infections Invasive Pulmonary Aspergillosis Liver Diseases Lung Diseases Lung Diseases, Fungal Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Pulmonary Aspergillosis Respiratory Tract Diseases Respiratory Tract Infections Viral Pneumonia Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Belgium

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. Radiological characteristics of IPA

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

    Chest CT

  3. Mycological characteristics of IPA

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

    Galactomannan testing, Aspergillus PCR, mycological culture

  4. Impact of IPA on length of ICU stay

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

  5. Impact of IPA on length of hospital stay

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

  6. Impact of IPA on mortality

    Time frame: From ICU admission until 90 days post-admission

  7. Impact of IPA on liver transplant eligibility

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

  8. Impact of IPA on liver transplant delisting

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

  9. 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.

  10. 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.

  11. Correlation of pre-mortem data with post-mortem lung tissue findings

    Time frame: Through study completion, an average of 3 years

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Gilead Sciences

Registry information

Acronym: LIVERIPA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2025
Registry last updated
Mar 4, 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.

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