PACIFIC: ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition

• Sponsor: University of Cologne (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04533087
• Collaborator: Universitätsklinikum Hamburg-Eppendorf (Other), Ludwig-Maximilians - University of Munich (Other)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 59
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Invasive Fungal Infections	Other: No intervention

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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition
• Actual Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Aug 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Age ≥18 years

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

• Signed ICF

Exclusion Criteria:

• None.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum der Universität zu Köln	Köln		Germany	50924

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sibylle C Mellinghoff, Resident physician and research affiliate, University of Cologne
• ClinicalTrials.gov Identifier: NCT04533087
• Other Study ID Numbers: PACIFIC
• First Posted: Aug 31, 2020
• Last Update Posted: Dec 17, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sibylle C Mellinghoff, Resident physician and research affiliate, University of Cologne: immune checkpoint; invasive fungal infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections

Study Results

No Results Posted as of Dec 17, 2020