ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition
PACIFIC
1 other identifier
observational
50
1 country
1
Brief Summary
This observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (IFI) against healthy controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 27, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedNovember 1, 2022
October 1, 2022
4.8 years
August 27, 2020
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Determination of lymphocytic immune phenotypes in BAL and other biopsy samples by flowcytometry
3 years
Measurement of cytotoxic T cell responses in blood samples from patients with IFI by ELISA
3 years
Correlation of survival at day 30 and 90 and immune checkpoint expression levels
4 years
Study Arms (3)
Candida blood stream infection
Aspergillosis
Rare mold infections
Interventions
Eligibility Criteria
Patients with IFI and healthy controls
You may qualify if:
- Age ≥18 years
- Proven or probable, incl. PCR, positive IFI along 2019 EORTC/MSG criteria
- Signed ICF
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colognelead
- Universitätsklinikum Hamburg-Eppendorfcollaborator
- Ludwig-Maximilians - University of Munichcollaborator
Study Sites (1)
Klinikum der Universität zu Köln
Cologne, 50924, Germany
Related Publications (1)
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.
PMID: 34921845DERIVED
Biospecimen
Peripheral blood and biopsy (e.g. BAL)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident physician and research affiliate
Study Record Dates
First Submitted
August 27, 2020
First Posted
August 31, 2020
Study Start
January 1, 2017
Primary Completion
October 1, 2021
Study Completion
October 1, 2022
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share