An observational study in Invasive Candidiasis, sponsored by University Hospital Ostrava. Recruiting at 2 sites in Czechia. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by University Hospital Ostrava · Observational
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.
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.
65 studies on the registry are indexed under Candidiasis, Invasive; 6 are open to participants now.
This study's planned enrollment of 100 is below the median of 162 across 17 observational studies indexed under Candidiasis, Invasive.
Browse Candidiasis, Invasive studies →University Hospital Ostrava is the lead sponsor of 148 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with suspected invasive candidasis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with suspected invasive candidiasis will be enrolled in this study arm.
Diagnostic Test: Invasive candidiasis test · Other: Urine sample collection for future research
The combination of acute phase marker monitoring and the T2Candida assay will be assessed.
Patients will be asked to provide a urine sample for future research (urine biobank).
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One-time measurement at the enrolment into the study
Plan to share: No — There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Started Apr 2024 (actual). Primary completion is estimated for Dec 2025, 20 months after the start.
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