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Completed

NCT Number: NCT04533087

ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition

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

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Key information

Conditions

Invasive Fungal Infections Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum der Universität zu Köln

Cologne, 50924, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Collaborators

  • Ludwig-Maximilians - University of Munich
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Acronym: PACIFIC

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Aug 31, 2020
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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