Invasive Candidiasis in Critical Care

University Hospital Ostrava

Status

Enrolling

Conditions

Invasive Candidiasis

Treatments

Other: Urine sample collection for future research

Diagnostic Test: Invasive candidiasis test

Study type

Observational

Funder types

Other

Identifiers

NCT06456151

SGS06/LF/2024 (Other Grant/Funding Number)

ULM-01-Invasive candidiasis

03/RVO-FNOs/2024 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

12+ months old

Volunteers

No Healthy Volunteers

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