An observational study in Fungal Infection and Candidiasis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Mayo Clinic · Observational
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.
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.
132 studies on the registry are indexed under Candidiasis; 9 are open to participants now.
This study's enrollment of 87 is below the median of 162 across 39 observational studies indexed under Candidiasis.
Browse Candidiasis studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Compared within Candidiasis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mycoses. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with Candida bloodstream infection, peritonitis/intra-abdominal abscess, and pleural empyema
Subjects must meet all following inclusion criteria to qualify for the study:
Exclusion Criteria
Subjects must NOT meet any of the following exclusion criteria to qualify for the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All-cause mortality
All-cause mortality
Time frame: 30 days
Serum concentration of IFN-gamma and other cytokines by multiplex ELISA
Serum concentration of IFN-gamma and other cytokines by multiplex ELISA
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 week
Ran from Feb 2022 to primary completion in Aug 2024, 30 months.
Of 14 observational studies under Candidiasis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 33. This study's 30 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.