ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition

Study Overview
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Brief Summary
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This observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (IFI) against healthy controls.

Detailed Description
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Participating sites will screen patients with invasive aspergillosis for eligibility. The investigators will enroll patients with aspergillosis and healthy controls. Patients will be informed by study personnel. Samples for imune phenotyping will be obtained within 7 days after diagnosis of IFI. A bronchoalveolar lavage (BAL) biopsy is taken at initial diagnostic bronchoscopy or other biopsy during surgical debridement whenever applicable and feasible. The following data items will be collected: Patient characteristics, details on invasive fungal infection (IFI), underlying disease, outcome after 90 days (response, remission, progress, death). All collected data will be interpreted at the end of the study. All patients must agree to participate and sign the informed consent form. The primary objective is to compare immune checkpoint expression in blood samples from patients with IFI against healthy controls. Exploratively, lymphocytic immune phenotypes in BAL or other biopsy samples from patients with IFI will be assessed. Further, cytotoxic T cell responses in blood samples from patients with IFI shall be investigated and the level of immune checkpoint expression correlated with mortality.

Official Title
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ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition

Conditions
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Invasive Fungal Infections

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Proven or probable, incl. PCR, positive IFI along 2019 EORTC/MSG criteria Signed ICF Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Candida blood stream infection<br> | Other: No intervention<br>* No intervention<br>|
| Aspergillosis<br> | Other: No intervention<br>* No intervention<br>|
| Rare mold infections<br> | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of immune checkpoint expression levels in blood samples from patients with IFI and healthy controls by flowcytometry | To compare immune checkpoint expression in blood samples from patients with IFI against healthy controls. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of lymphocytic immune phenotypes in BAL and other biopsy samples by flowcytometry | To assess lymphocytic immune phenotypes in BAL and other biopsy samples from patients with IFI. | 3 years | 
| Measurement of cytotoxic T cell responses in blood samples from patients with IFI by ELISA | Assessment of T cell response on lymphocytes from peripheral blood | 3 years | 
| Correlation of survival at day 30 and 90 and immune checkpoint expression levels | To correlate the level of immune checkpoint expression with mortality. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immune checkpoint, invasive fungal infection