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| Name | Class |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| Ludwig-Maximilians - University of Munich | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candida blood stream infection |
| ||
| Aspergillosis |
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| Rare mold infections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with IFI and healthy controls
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der Universität zu Köln | Cologne | 50924 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34921845 | Derived | Mellinghoff SC, Thelen M, Bruns C, Garcia-Marquez M, Hartmann P, Lammertz T, Lehmann J, Nowag A, Stemler J, Wennhold K, Cornely OA, von Bergwelt-Baildon MS, Schlosser HA. T-cells of invasive candidiasis patients show patterns of T-cell-exhaustion suggesting checkpoint blockade as treatment option. J Infect. 2022 Feb;84(2):237-247. doi: 10.1016/j.jinf.2021.12.009. Epub 2021 Dec 15. |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Peripheral blood and biopsy (e.g. BAL)
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 |