ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition

Invasive Fungal Infections Clinical Trial

— PACIFIC  

Official title:

ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533087
• Other study ID #: PACIFIC
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: October 2022

Study information

• Verified date: October 2022
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (IFI) against healthy controls.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2022
• Est. primary completion date: October 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Proven or probable, incl. PCR, positive IFI along 2019 EORTC/MSG criteria

• Signed ICF

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Invasive Fungal Infections
• Mycoses

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Germany	Klinikum der Universität zu Köln	Köln

Sponsors (3)

Lead Sponsor	Collaborator
University of Cologne	Ludwig-Maximilians - University of Munich, Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Measurement of cytotoxic T cell responses in blood samples from patients with IFI by ELISA	Assessment of T cell response on lymphocytes from peripheral blood	3 years
Secondary	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