ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition (PACIFIC)

October 31, 2022 updated by: Sibylle C Mellinghoff, University of Cologne
This observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (IFI) against healthy controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Köln, Germany, 50924
        • Klinikum der Universität zu Köln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with IFI and healthy controls

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Candida blood stream infection
Other: No intervention
No intervention
Aspergillosis
Other: No intervention
No intervention
Rare mold infections
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of immune checkpoint expression levels in blood samples from patients with IFI and healthy controls by flowcytometry
Time Frame: 3 years
To compare immune checkpoint expression in blood samples from patients with IFI against healthy controls.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of lymphocytic immune phenotypes in BAL and other biopsy samples by flowcytometry
Time Frame: 3 years
To assess lymphocytic immune phenotypes in BAL and other biopsy samples from patients with IFI.
3 years
Measurement of cytotoxic T cell responses in blood samples from patients with IFI by ELISA
Time Frame: 3 years
Assessment of T cell response on lymphocytes from peripheral blood
3 years
Correlation of survival at day 30 and 90 and immune checkpoint expression levels
Time Frame: 4 years
To correlate the level of immune checkpoint expression with mortality.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

Ludwig-Maximilians - University of Munich
Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACIFIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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