Invasive Fungal Infections
Conditions
Keywords
immune checkpoint, invasive fungal infection
Brief summary
This observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (IFI) against healthy controls.
Detailed description
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Ludwig-Maximilians - University of Munich
University of Cologne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Age ≥18 years * Proven or probable, incl. PCR, positive IFI along 2019 EORTC/MSG criteria * Signed ICF
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of immune checkpoint expression levels in blood samples from patients with IFI and healthy controls by flowcytometry | 3 years | To compare immune checkpoint expression in blood samples from patients with IFI against healthy controls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of lymphocytic immune phenotypes in BAL and other biopsy samples by flowcytometry | 3 years | To assess lymphocytic immune phenotypes in BAL and other biopsy samples from patients with IFI. |
| Measurement of cytotoxic T cell responses in blood samples from patients with IFI by ELISA | 3 years | Assessment of T cell response on lymphocytes from peripheral blood |
| Correlation of survival at day 30 and 90 and immune checkpoint expression levels | 4 years | To correlate the level of immune checkpoint expression with mortality. |
Countries
Germany
Outcome results
None listed