Clinical trial NCT04533087: ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition
Official title: ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Fungal Infections
Keywords: immune checkpoint
invasive fungal infection
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
name: Ludwig-Maximilians - University of Munich
First posted: 2020-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with IFI and healthy controls

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Proven or probable, incl. PCR, positive IFI along 2019 EORTC/MSG criteria
* Signed ICF

Exclusion Criteria:

* None.

Primary outcomes:
measure: Measurement of immune checkpoint expression levels in blood samples from patients with IFI and healthy controls by flowcytometry
timeFrame: 3 years
Secondary outcomes:
measure: Determination of lymphocytic immune phenotypes in BAL and other biopsy samples by flowcytometry
timeFrame: 3 years
measure: Measurement of cytotoxic T cell responses in blood samples from patients with IFI by ELISA
timeFrame: 3 years
measure: Correlation of survival at day 30 and 90 and immune checkpoint expression levels
timeFrame: 4 years
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Klinikum der Universität zu Köln
Study officials:
References:
citation: 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.