Clinical trial NCT05235711: The Role of Interferon-gamma in Immune Responses to Invasive Candidiasis
Official title: The Role of Interferon-gamma in Immune Responses to Invasive Candidiasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fungal Infection
Candidiasis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Candida bloodstream infection, peritonitis/intra-abdominal abscess, and pleural empyema

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: Serum concentration of IFN-gamma and other cytokines by multiplex ELISA
timeFrame: 1 week
measure: Plasma IFN-gamma concentration after dual innate and adaptive immune system stimulation by QuantiFERON Monitor assay
timeFrame: 1 week
measure: Intracellular expression of IFN-gamma expression by a CD8 T-cell competence assay
timeFrame: 1 week
measure: In vitro antifungal activity of polymorphonuclear leukocytes in the presence or absence of interferon-gamma by colorimetric method
timeFrame: 1 week
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Paschalis Vergidis, MD
role: PRINCIPAL_INVESTIGATOR
References: