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NCT Number: NCT06456151

Invasive Candidiasis in Critical Care

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.

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Key information

Conditions

Invasive Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Infections Invasive Fungal Infections Mycoses

Age range

12 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ostrava, Ostrava, Moravian-Silesian Region, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Invasive candidiasis test

Diagnostic Test

The combination of acute phase marker monitoring and the T2Candida assay will be assessed.

Urine sample collection for future research

Other

Patients will be asked to provide a urine sample for future research (urine biobank).

Primary outcomes

  1. Acute-phase biomarkers dynamics - procalcitonin

    Time frame: 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.

  2. Acute-phase biomarkers dynamics - interleukin-6

    Time frame: 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.

  3. Acute-phase biomarkers dynamics - interleukin-10

    Time frame: 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.

  4. Acute-phase biomarkers dynamics - Presepsin

    Time frame: 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.

  5. Acute-phase biomarkers dynamics - C-reactive protein

    Time frame: 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.

  6. Acute-phase biomarkers dynamics - 1,3-β-D-glucan

    Time frame: 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.

  7. Acute-phase biomarkers dynamics - pentraxin 3

    Time frame: 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.

  8. T2Candida test

    Time frame: 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.

  9. Lipopolysaccharide binding protein

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • University Hospital, Motol

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jun 13, 2024
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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