Liver CirrhosisLIVERIPANCT07238114
Liver Cirrhosis Patients With Invasive Pulmonary Aspergillosis: in Depth Understanding Clinical Host Risk Factors
An observational study of Liver Cirrhosis and Viral Pneumonia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Viral Pneumonia, Fungal Infection
- How many people
- 450 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2025to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with known or suspected liver cirrhosis who were admitted to the Medical ICU of UZ Leuven.
Who may be able to join
- All adults (≥ 18 years old)
- Chronic liver disease
- Admission to the Medical Intensive Care Unit of University Hospitals of Leuven
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Liver Cirrhosis, Pneumonia, Viral, Mycoses, Invasive Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From the date of ICU admission until ICU discharge, approximately 7 days
Secondary outcomes (11)
Clinical characteristics of IPA
Baseline characteristics, organ failures, organ support, outcome parameters
Measured: From the date of ICU admission until ICU discharge, approximately 7 days
Radiological characteristics of IPA
Chest CT
Measured: From the date of ICU admission until ICU discharge, approximately 7 days
Mycological characteristics of IPA
Galactomannan testing, Aspergillus PCR, mycological culture
Measured: From the date of ICU admission until ICU discharge, approximately 7 days
Impact of IPA on length of ICU stay
Measured: From the date of ICU admission until ICU discharge, approximately 7 days
Impact of IPA on length of hospital stay
Measured: From the date of ICU admission until hospital discharge, approximately 36 days
Impact of IPA on mortality
Measured: From ICU admission until 90 days post-admission
Impact of IPA on liver transplant eligibility
Measured: From the date of ICU admission until ICU discharge, approximately 7 days
Impact of IPA on liver transplant delisting
Measured: From the date of ICU admission until ICU discharge, approximately 7 days
Histological characteristics of IPA using tissue staining
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.
Measured: Through study completion, an average of 3 years
Histological characteristics of IPA using microbiological testing
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.
Measured: Through study completion, an average of 3 years
Correlation of pre-mortem data with post-mortem lung tissue findings
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Aug 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Joost Wauters, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238114
- Sponsor's protocol ID
- S68965
- Other IDs
- IN-BE-131-7804
- Acronym
- LIVERIPA
- Status last verified
- Mar 2026
- First submitted
- 9 Sep 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Cirrhosis Patients With Invasive Pulmonary Aspergillosis: in Depth Understanding Clinical Host Risk Factors
- ClinicalTrials.gov ID
- NCT07238114
- Acronym / sponsor ID
- LIVERIPA / S68965
- Conditions
- Liver Cirrhosis, Viral Pneumonia, Fungal Infection, Invasive Pulmonary Aspergillosis, Intensive Care Medicine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with known or suspected liver cirrhosis who were admitted to the Medical ICU of UZ Leuven.
Key inclusion criteria (3 listed)
- All adults (≥ 18 years old)
- Chronic liver disease
- Admission to the Medical Intensive Care Unit of University Hospitals of Leuven
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
11 secondary outcomes
Clinical characteristics of IPA
Time frame: 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
Mycological characteristics of IPA
Time frame: From the date of ICU admission until ICU discharge, approximately 7 days
Impact of IPA on length of ICU stay
Time frame: 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
Impact of IPA on mortality
Time frame: From ICU admission until 90 days post-admission
Impact of IPA on liver transplant eligibility
Time frame: From the date of ICU admission until ICU discharge, approximately 7 days
Impact of IPA on liver transplant delisting
Time frame: 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 using microbiological testing
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost Wauters, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Viral Pneumonia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPA incidence (time frame: From the date of ICU admission until ICU discharge, approximately 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.