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The Role Of Interferon-gamma In Immune Responses To Invasive Candidiasis

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05235711
Collaborator
(none)
150
Enrollment
1
Location
21.7
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    The Role Of Interferon-gamma In Immune Responses To Invasive Candidiasis
    Actual Study Start Date :
    Feb 10, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality [30 days]

      All-cause mortality

    Secondary Outcome Measures

    1. Serum concentration of IFN-gamma and other cytokines by multiplex ELISA [1 week]

      Serum concentration of IFN-gamma and other cytokines by multiplex ELISA

    2. Plasma IFN-gamma concentration after dual innate and adaptive immune system stimulation by QuantiFERON Monitor assay [1 week]

      Plasma IFN-gamma concentration after dual innate and adaptive immune system stimulation by QuantiFERON Monitor assay

    3. Intracellular expression of IFN-gamma expression by a CD8 T-cell competence assay [1 week]

      Intracellular expression of IFN-gamma expression by a CD8 T-cell competence assay

    4. In vitro antifungal activity of polymorphonuclear leukocytes in the presence or absence of interferon-gamma by colorimetric method [1 week]

      In vitro antifungal activity of polymorphonuclear leukocytes in the presence or absence of interferon-gamma by colorimetric method

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Subjects must meet all following inclusion criteria to qualify for the study:

    1. Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.

    2. Males or females ≥18 years of age

    3. Patients having one or more systemic signs attributable to candidemia or invasive candidiasis (fever, hypothermia, hypotension, tachycardia, tachypnea, local signs of inflammation).

    4. Isolation of Candida from blood, intra-abdominal abscess/peritoneal fluid or pleural fluid.

    Exclusion Criteria

    Subjects must NOT meet any of the following exclusion criteria to qualify for the study:

    1. Severe neutropenia (absolute neutrophil count <500 cells/microL)

    2. Profound lymphopenia (<300 cells/microL)

    3. The Principal Investigator (PI) is of the opinion the subject should not participate in the study.

    4. Females who are pregnant.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Paschalis Vergidis, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Paschalis Vergidis, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05235711
    Other Study ID Numbers:
    • 21-008735
    First Posted:
    Feb 11, 2022
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Candidiasis
    Mycoses
    Candidiasis, Invasive

    Study Results

    No Results Posted as of Mar 15, 2022