Invasive Candidiasis in Critical Care

NCT06456151 | Recruiting

• 3 other identifiers: ULM-01-Invasive candidiasis03/RVO-FNOs/2024SGS06/LF/2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Invasive Candidiasis

Keywords

invasive candidiasis; biomarkers; candida sepsis

Outcome Measures

Primary Outcomes (9)

• 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.

  8 days

• 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.

  8 days

• 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.

  8 days

• 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.

  8 days

• Acute-phase biomarkers dynamics - C-reactive protein

  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.

  8 days

• Acute-phase biomarkers dynamics - 1,3-β-D-glucan

  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.

  8 days

• Acute-phase biomarkers dynamics - pentraxin 3

  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 days

• T2Candida test

  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.

  One-time measurement at the enrolment into the study

• Lipopolysaccharide binding protein

  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.

  One-time measurement at the enrolment into the study

Study Arms (1)

Patients with suspected invasive candidiasis

Patients with suspected invasive candidiasis will be enrolled in this study arm.

Diagnostic Test: Invasive candidiasis test; Other: Urine sample collection for future research

Interventions

Invasive candidiasis test DIAGNOSTIC_TEST

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

Patients with suspected invasive candidiasis

Urine sample collection for future research OTHER

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

Patients with suspected invasive candidiasis

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected invasive candidasis.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• University Hospital, Motol: collaborator

Study Sites (2)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

RECRUITING

University Hospital Motol

Prague, 150 06, Czechia

RECRUITING

Related Publications (2)

• Dobias R, Kanova M, Petejova N, Pisti SK, Bocek R, Krejci E, Struzkova H, Cachova M, Tomaskova H, Hamal P, Havlicek V, Raska M. Combined Use of Presepsin and (1,3)-beta-D-glucan as Biomarkers for Diagnosing Candida Sepsis and Monitoring the Effectiveness of Treatment in Critically Ill Patients. J Fungi (Basel). 2022 Mar 17;8(3):308. doi: 10.3390/jof8030308.

  PMID: 35330311 BACKGROUND

• Bassetti M, Giacobbe DR, Vena A, Wolff M. Diagnosis and Treatment of Candidemia in the Intensive Care Unit. Semin Respir Crit Care Med. 2019 Aug;40(4):524-539. doi: 10.1055/s-0039-1693704. Epub 2019 Oct 4.

  PMID: 31585478 BACKGROUND

Related Links

• World Health Organisation (WHO) fungal priority pathogens list to guide research, development and public health action

Biospecimen

Retention: SAMPLES WITHOUT DNA

Left-over blood samples from patients will be used in the study. The study subjects will be also asked for a sample of urine.

MeSH Terms

Conditions

Candidiasis, Invasive

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Study Officials

• Hana Slepčanová, Mgr.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 13, 2024
• Study Start: April 11, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)