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.

Study Overview

• Status: Recruiting
• Conditions: Candidiasis; Fungal Infection

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Bjerke Jacob; Phone Number: 507-255-8464; Email: bejrke.jacob@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Candida bloodstream infection, peritonitis/intra-abdominal abscess, and pleural empyema

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration of IFN-gamma and other cytokines by multiplex ELISA	Serum concentration of IFN-gamma and other cytokines by multiplex ELISA	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	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	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	1 week

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Paschalis Vergidis, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Invasive Fungal Infections; Candidiasis; Candidiasis, Invasive; Mycoses
• Other Study ID Numbers: 21-008735

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No