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Invasive Candidiasis in Critical Care

ConditionInvasive Candidiasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorUniversity Hospital Ostrava

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with suspected invasive candidasis.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients with suspected invasive candidiasis2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
8 days
2

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.

Time frame
8 days
3

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.

Time frame
8 days
4

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.

Time frame
8 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Ostrava

Lead sponsor

University Hospital, Motol

Collaborator

Source ClinicalTrials.gov
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