Improving diagnosis of invasive candidiasis in critically ill patients
Official title: Invasive Candidiasis in Critical Care
Run by University Hospital Ostrava · NCT06456151 · Data updated 2026-11-12
This study is testing a new way to quickly and accurately diagnose invasive candidiasis in critically ill patients by using a combination of blood tests.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Months and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 2 sites (Ostrava, Moravian-Silesian Region and 1 other locations) |
| Status | Recruiting |
| Started | April 11, 2024 |
| Main results expected | December 2025 |
| Study ends | December 2027 |
| Registry record updated | June 5, 2025 |
| Trial ID | NCT06456151 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are critically ill patients with new onset sepsis and evidence of Candida colonization from multiple non-sterile sites.
✕Probably not a fit
Patients who have already received antifungal therapy prior to the collection of biological material will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on enhancing the diagnosis of invasive candidiasis in critically ill patients by combining acute phase marker monitoring with the T2Candida assay. The aim is to accelerate the identification of the causative agent of mycotic infections, thereby improving specificity and positive predictive value in diagnosing invasive candidiasis and candidemia. By analyzing the kinetics of new acute phase markers alongside traditional methods, the study seeks to reduce the time to diagnosis and improve patient outcomes in intensive care settings.
Why it matters
Potential benefit: If successful, this approach could lead to faster and more accurate diagnoses of invasive candidiasis, ultimately improving patient care and reducing treatment costs.
How similar studies have gone: Other studies have shown promise in using molecular biology-based tests for rapid pathogen identification, indicating that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia Recruiting -
University Hospital Motol
Prague, Czechia Recruiting
Study contacts
- Principal investigator: Hana Slepčanová, Mgr. — University Hospital Ostrava
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: 0042059737
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing antifungal treatment durations for children with uncomplicated candidemia
This study is testing if giving children with uncomplicated candidemia an extra 7 days of antifungal treatment helps them recover better than stopping treatment after the first week.
-
Treatment of serious fungal infections with Fosmanogepix
This study is testing if a new treatment called Fosmanogepix can help people with serious fungal infections like candidemia and invasive candidiasis do better than the usual treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.