Invasive Fungal InfectionsPACIFICNCT04533087
ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition
An observational study of Invasive Fungal Infections, run by University of Cologne at 1 site in Germany.
Trial summary
This observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (IFI) against healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Fungal Infections
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2017to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with IFI and healthy controls
Who may be able to join
- Age ≥18 years
- Proven or probable, incl. PCR, positive IFI along 2019 EORTC/MSG criteria
- Signed ICF
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
This observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (IFI) against healthy controls.
Read the 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.
- Conditions
- Invasive Fungal Infections
- Being tested
- No intervention
- Keywords
- immune checkpoint, invasive fungal infection
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Candida blood stream infection | Not described Receives: Other: No intervention | |
| Aspergillosis | Not described Receives: Other: No intervention | |
| Rare mold infections | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
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.
Measured: 3 years
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
Measured: 3 years
Correlation of survival at day 30 and 90 and immune checkpoint expression levels
To correlate the level of immune checkpoint expression with mortality.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Jan 2017
- Primary completionOct 2021
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Sibylle C Mellinghoff, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533087
- Sponsor's protocol ID
- PACIFIC
- Acronym
- PACIFIC
- Status last verified
- Oct 2022
- First submitted
- 27 Aug 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mellinghoff SC, Thelen M, Bruns C, Garcia-Marquez M, Hartmann P, Lammertz T, Lehmann J, Nowag A, Stemler J, Wennhold K, Cornely OA, von Bergwelt-Baildon MS, Schlosser HA. T-cells of invasive candidiasis patients show patterns of T-cell-exhaustion suggesting checkpoint blockade as treatment option. J Infect. 2022 Feb;84(2):237-247. doi: 10.1016/j.jinf.2021.12.009. Epub 2021 Dec 15.
PubMed 34921845
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition
- ClinicalTrials.gov ID
- NCT04533087
- Acronym / sponsor ID
- PACIFIC / PACIFIC
- Conditions
- Invasive Fungal Infections
- Keywords
- immune checkpoint, invasive fungal infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Ludwig-Maximilians - University of Munich
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Candida blood stream infection | – | Other: No intervention |
| Aspergillosis | – | Other: No intervention |
| Rare mold infections | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with IFI and healthy controls
Key inclusion criteria (3 listed)
- Age ≥18 years
- Proven or probable, incl. PCR, positive IFI along 2019 EORTC/MSG criteria
- Signed ICF
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Aspergillosis, Candida blood stream infection, Rare mold infections |
Primary outcome
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 secondary outcomes
Determination of lymphocytic immune phenotypes in BAL and other biopsy samples by flowcytometry
Time frame: 3 years
Measurement of cytotoxic T cell responses in blood samples from patients with IFI by ELISA
Time frame: 3 years
Correlation of survival at day 30 and 90 and immune checkpoint expression levels
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 34921845Mellinghoff SC, Thelen M, Bruns C, Garcia-Marquez M, Hartmann P, Lammertz T, Lehmann J, Nowag A, Stemler J, Wennhold K, Cornely OA, von Bergwelt-Baildon MS, Schlosser HA. T-cells of invasive candidiasis patients show patterns of T-cell-exhaustion suggesting checkpoint blockade as treatment option. J Infect. 2022 Feb;84(2):237-247. doi: 10.1016/j.jinf.2021.12.009. Epub 2021 Dec 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infections, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of immune checkpoint expression levels in blood samples from patients with IFI and healthy controls by flowcytometry (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04533087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.