Fungal InfectionNCT05235711
The Role of Interferon-gamma in Immune Responses to Invasive Candidiasis
An observational study of Fungal Infection and Candidiasis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of the study is to investigate the role of the human immune response to candidemia/invasive candidiasis as it relates to the cytokine interferon-gamma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Infection, Candidiasis
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 31 Aug 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Candida bloodstream infection, peritonitis/intra-abdominal abscess, and pleural empyema
Who may be able to join
None listed.
Who cannot join
- Subjects must NOT meet any of the following exclusion criteria to qualify for the study:
- Severe neutropenia (absolute neutrophil count <500 cells/microL)
- Profound lymphopenia (<300 cells/microL)
- The Principal Investigator (PI) is of the opinion the subject should not participate in the study.
- Females who are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate the role of the human immune response to candidemia/invasive candidiasis as it relates to the cytokine interferon-gamma.
Read the detailed description
In this study, patients with Candida bloodstream infection, peritonitis/intra-abdominal abscess, and pleural empyema will be enrolled.
Persistent candidiasis confirmed by culture will be defined as follows: (i) Candida bloodstream infection present for >48 hours after initiation of effective antifungal treatment and after removal of intravenous devices, (ii) Intra-abdominal infection (peritonitis or abscess) that persists for >96 hours after source control intervention and effective antifungal treatment, (iii) Pleural empyema that persists for >96 hours after placement of drainage catheter and effective antifungal treatment.
Outcomes in patients with and without persistent candidiasis will be assessed.
- Conditions
- Fungal Infection, Candidiasis
- Medical subject headings
- Mycoses, Candidiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality
Measured: 30 days
Secondary outcomes (4)
Serum concentration of IFN-gamma and other cytokines by multiplex ELISA
Serum concentration of IFN-gamma and other cytokines by multiplex ELISA
Measured: 1 week
Plasma IFN-gamma concentration after dual innate and adaptive immune system stimulation by QuantiFERON Monitor assay
Plasma IFN-gamma concentration after dual innate and adaptive immune system stimulation by QuantiFERON Monitor assay
Measured: 1 week
Intracellular expression of IFN-gamma expression by a CD8 T-cell competence assay
Intracellular expression of IFN-gamma expression by a CD8 T-cell competence assay
Measured: 1 week
In vitro antifungal activity of polymorphonuclear leukocytes in the presence or absence of interferon-gamma by colorimetric method
In vitro antifungal activity of polymorphonuclear leukocytes in the presence or absence of interferon-gamma by colorimetric method
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start10 Feb 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paschalis Vergidis, Mayo Clinic
- Investigators
- Paschalis Vergidis, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235711
- Sponsor's protocol ID
- 21-008735
- Status last verified
- Oct 2024
- First submitted
- 4 Jan 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Interferon-gamma in Immune Responses to Invasive Candidiasis
- ClinicalTrials.gov ID
- NCT05235711
- Acronym / sponsor ID
- 21-008735
- Conditions
- Fungal Infection, Candidiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 11 Feb 2022 (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.
The purpose of the study is to investigate the role of the human immune response to candidemia/invasive candidiasis as it relates to the cytokine interferon-gamma.
Detailed description
In this study, patients with Candida bloodstream infection, peritonitis/intra-abdominal abscess, and pleural empyema will be enrolled.
Persistent candidiasis confirmed by culture will be defined as follows: (i) Candida bloodstream infection present for >48 hours after initiation of effective antifungal treatment and after removal of intravenous devices, (ii) Intra-abdominal infection (peritonitis or abscess) that persists for >96 hours after source control intervention and effective antifungal treatment, (iii) Pleural empyema that persists for >96 hours after placement of drainage catheter and effective antifungal treatment.
Outcomes in patients with and without persistent candidiasis will be assessed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Candida bloodstream infection, peritonitis/intra-abdominal abscess, and pleural empyema
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Severe neutropenia (absolute neutrophil count <500 cells/microL)
- Profound lymphopenia (<300 cells/microL)
- The Principal Investigator (PI) is of the opinion the subject should not participate in the study.
- Females who are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: 30 days
All-cause mortality
4 secondary outcomes
Serum concentration of IFN-gamma and other cytokines by multiplex ELISA
Time frame: 1 week
Plasma IFN-gamma concentration after dual innate and adaptive immune system stimulation by QuantiFERON Monitor assay
Time frame: 1 week
Intracellular expression of IFN-gamma expression by a CD8 T-cell competence assay
Time frame: 1 week
In vitro antifungal activity of polymorphonuclear leukocytes in the presence or absence of interferon-gamma by colorimetric method
Time frame: 1 week
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 9 Oct 2024.
- Mayo Clinical TrialLink provided by the sponsor.
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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.
Paschalis Vergidis, MD principal investigator
Mayo Clinic
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 Fungal Infection and Candidiasis, run by Mayo Clinic at 1 site in United States.
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 0 inclusion and 5 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 9 Oct 2024. 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 United States. 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?
All-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2024.