Candidiasis, Fungal Infection
Conditions
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.
Interventions
None listed
Sponsors
Mayo Clinic
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30 days | All-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentration of IFN-gamma and other cytokines by multiplex ELISA | 1 week | Serum concentration of IFN-gamma and other cytokines by multiplex ELISA |
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed