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

Completed

• Conditions: Fungal Infection; Candidiasis

• Registration Number: NCT05235711
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-02-01
• Study Start: 2022-02-10
• Study First Posted: 2022-02-11
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	30 days	All-cause mortality

Secondary Outcome Measures

Name	Time	Method
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
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
Serum concentration of IFN-gamma and other cytokines by multiplex ELISA	1 week	Serum concentration of IFN-gamma and other cytokines by multiplex ELISA
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

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States