ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition
NCT ID: NCT04533087
Last Updated: 2022-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2017-01-01
2022-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Candida blood stream infection
No intervention
No intervention
Aspergillosis
No intervention
No intervention
Rare mold infections
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* Proven or probable, incl. PCR, positive IFI along 2019 EORTC/MSG criteria
* Signed ICF
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Ludwig-Maximilians - University of Munich
OTHER
University of Cologne
OTHER
Responsible Party
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Sibylle C Mellinghoff
Resident physician and research affiliate
Locations
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Klinikum der Universität zu Köln
Cologne, , Germany
Countries
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References
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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.
Other Identifiers
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PACIFIC
Identifier Type: -
Identifier Source: org_study_id
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