ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition

Completed

• Conditions: Invasive Fungal Infections
• Interventions: Other: No intervention

• Registration Number: NCT04533087
• Lead Sponsor: University of Cologne

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-08-31
• Primary Completion: 2021-10
• Status Verified: 2022-10
• Study Completion: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Candida blood stream infection	No intervention	-
Aspergillosis	No intervention	-
Rare mold infections	No intervention	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Klinikum der Universität zu Köln; 🇩🇪 Köln, Germany