RecruitingNCT06456151

Invasive Candidiasis in Critical Care


Sponsor

University Hospital Ostrava

Enrollment

100 participants

Start Date

Apr 11, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 12 Months

Inclusion Criteria6

  • 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 Criteria2

  • 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

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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).


Locations(2)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

University Hospital Motol

Prague, Czechia

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NCT06456151


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