Invasive Candidiasis in Critical Care
NCT Number: NCT06456151
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Invasive Candidiasis
Interventions: DIAGNOSTIC_TEST: Invasive candidiasis test|OTHER: Urine sample collection for future research
Sponsor: University Hospital Ostrava
Collaborators: University Hospital, Motol
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-11
Completion Date: 2027-12
Locations: University Hospital Ostrava, Ostrava, Moravian-Silesian Region, 708 52, Czechia|University Hospital Motol, Prague, 150 06, Czechia

Summary:
The combination of acute phase marker monitoring and the "T2Candida" assay (name of the test) will represent an acceleration of the identification of the causative agent of mycotic infection, a significant improvement in the specificity and positive predictive value of this strategy in the diagnosis of invasive candidiasis and candidemia in ICU patients, thereby improving the clinical condition of patients and reducing the cost of specific antifungal therapy.

Primary Outcome Measures: Acute-phase biomarkers dynamics - procalcitonin, The levels of procalcitonin will be observed in time and measured in μg/L. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition., 8 days|Acute-phase biomarkers dynamics - interleukin-6, The levels of interleukin-6 will be observed in time and measured in pg/ml. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition., 8 days|Acute-phase biomarkers dynamics - interleukin-10, The levels of interleukin-10 will be observed in time and measured in pg/ml. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition., 8 days|Acute-phase biomarkers dynamics - Presepsin, The levels of Presepsin will be observed in time and measured in pg/ml. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition., 8 days|Acute-phase biomarkers dynamics - C-reactive protein, The levels of C-reactive protein will be observed in time and measured in mg/dL.

The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition., 8 days|Acute-phase biomarkers dynamics - 1,3-β-D-glucan, The levels of C-reactive protein will be observed in time and measured in pg/ml.

The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition., 8 days|Acute-phase biomarkers dynamics - pentraxin 3, The levels of C-reactive protein will be observed in time and measured in ng/ml.

The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition., 8 days|T2Candida test, The T2Candida test is able to detect the presence of Candida albicans, C. tropicalis, C. glabrata, C. krusei and C. parapsilosis. The results will be assessed as positive or negative., One-time measurement at the enrolment into the study|Lipopolysaccharide binding protein, The levels of Lipopolysaccharide binding protein (LBP)_S/P will be observed in time and measured in mg/L.

The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition., One-time measurement at the enrolment into the study