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

Fungal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235711
• Other study ID #: 21-008735
• Status: Recruiting
• Start date: February 10, 2022
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Bjerke Jacob
• Phone: 507-255-8464
• Email: bejrke.jacob[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Fungal Infection
• Mycoses

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All-cause mortality	30 days
Secondary	Serum concentration of IFN-gamma and other cytokines by multiplex ELISA	Serum concentration of IFN-gamma and other cytokines by multiplex ELISA	1 week
Secondary	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
Secondary	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
Secondary	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