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OpenTrials
Completed

NCT Number: NCT05235711

The Role of Interferon-gamma in Immune Responses to Invasive Candidiasis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Subjects must meet all following inclusion criteria to qualify for the study:

  • 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.
  • Males or females ≥18 years of age
  • Patients having one or more systemic signs attributable to candidemia or invasive candidiasis (fever, hypothermia, hypotension, tachycardia, tachypnea, local signs of inflammation).
  • 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:

  • 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.

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 30 days

    All-cause mortality

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 11, 2022
Registry last updated
Oct 9, 2024

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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