Invasive Candidiasis
Conditions
Keywords
invasive candidiasis, biomarkers, candida sepsis
Brief 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.
Detailed description
Speed of response in the treatment of sepsis is crucial for the patient. The time from the collection of a positive haemoculture to the identification of the causative agent of sepsis is around 2 days; therefore, physicians in intensive care units deploy combined empiric antibiotic and antifungal therapy immediately when acute phase markers such as procalcitonin, interleukin-6, Presepsin, C-reactive protein are elevated. A new acute phase marker is lipopolysaccharide-binding protein, which, together with Presepsin, appears to be a suitable marker to distinguish invasive candida infections from bacterial infections. But its kinetics needs to be further analyzed. At the same time, the causative agent of sepsis, G-/G+ bacteria or yeast, must be identified as soon as possible. Haemoculture and culture of the established drain is the gold standard, but the disadvantage is the low sensitivity and the time delay to obtain the result. It is therefore advisable to combine haemoculture with molecular biology-based tests that can identify the causative organism within hours. Conversely, the disadvantage of these tests is that they identify only the most common sepsis pathogens and do not determine susceptibility to antibiotics and antifungals, but the advantage is that with prophylaxis in place, these tests are often positive when haemoculture is negative. The T2Candida test can detect Candida albicans, Candida tropicalis, Candida glabrata, Candida krusei and Candida parapsilosis, which are the more common causative agents of mycotic bloodstream infections.
Interventions
DIAGNOSTIC_TESTInvasive candidiasis test
The combination of acute phase marker monitoring and the T2Candida assay will be assessed.
OTHERUrine sample collection for future research
Patients will be asked to provide a urine sample for future research (urine biobank).
Sponsors
University Hospital, Motol
University Hospital Ostrava
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* critically ill patients * new onset sepsis * rise in body temperature \>38°C according to The Third Consensus Definitions for Sepsis and Septic Shock * colonization with Candida spp. from more than 1 non-sterile site * body temperature \>38 °C despite 5 days of broad-spectrum antibiotic therapy with the presence of at least 1 of the following risk factors: abdominal surgery, secondary peritonitis, pancreatitis, central venous catheter (CVC) insertion, total parenteral nutrition (CPV), dialysis, steroid therapy, immunosuppressive therapy, or liver transplantation * microbiological test results will be reviewed and categorized based on whether Candida sp. is isolated from at least 2 non-sterile sites (±3 days) and whether there is an alternative microbiological diagnosis.
Exclusion criteria
* not signing the informed consent with participation in the study * administration of antifungal therapy prior to collection of the biological material required for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute-phase biomarkers dynamics - procalcitonin | 8 days | 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. |
| Acute-phase biomarkers dynamics - interleukin-6 | 8 days | 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. |
| Acute-phase biomarkers dynamics - interleukin-10 | 8 days | 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. |
| Acute-phase biomarkers dynamics - Presepsin | 8 days | 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. |
| Acute-phase biomarkers dynamics - C-reactive protein | 8 days | 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. |
| Acute-phase biomarkers dynamics - 1,3-β-D-glucan | 8 days | 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. |
| Acute-phase biomarkers dynamics - pentraxin 3 | 8 days | 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. |
| T2Candida test | One-time measurement at the enrolment into the study | 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. |
| Lipopolysaccharide binding protein | One-time measurement at the enrolment into the study | 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. |
Countries
Czechia
Contacts
Primary ContactJiří Hynčica
Outcome results
None listed