Improving diagnosis of invasive candidiasis in critically ill patients
Invasive Candidiasis in Critical Care
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 12 Months and up |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 2 sites (Ostrava, Moravian-Silesian Region and 1 other locations) |
| Trial ID | NCT06456151 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have already received antifungal therapy prior to the collection of biological material will not benefit from this study.
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 performed: Other studies have shown promise in using molecular biology-based tests for rapid pathogen identification, indicating that this approach may be effective.
Eligibility criteria
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 this trial is running
Ostrava, Moravian-Silesian Region and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.