Invasive CandidiasisNCT06456151
Invasive Candidiasis in Critical Care
An observational study of Invasive Candidiasis, run by University Hospital Ostrava at 2 sites in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Invasive Candidiasis
- What is being tested?
- Invasive candidiasis test and Urine sample collection for future research
- How many people
- 100 participants
- Where
- 2 sitesCzechia
- Study dates
- 11 Apr 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected invasive candidasis.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites, 2 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Hana Slepčanová, Mgr.
- Recruiting
University Hospital Motol
Prague, 150 06
Vanda Chrenková, MD, 0042022443 ext. 5390, vanda.chrenkova@fnmotol.cz
Vanda Chrenková, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Invasive Candidiasis
- Being tested
- Invasive candidiasis test, Urine sample collection for future research
- Keywords
- invasive candidiasis, biomarkers, candida sepsis
- Medical subject headings
- Candidiasis, Invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive candidiasis testDiagnostic test
The combination of acute phase marker monitoring and the T2Candida assay will be assessed.
Urine sample collection for future researchOther
Patients will be asked to provide a urine sample for future research (urine biobank).
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected invasive candidiasis | Patients with suspected invasive candidiasis will be enrolled in this study arm. Receives: Diagnostic Test: Invasive candidiasis test; Other: Urine sample collection for future research |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One-time measurement at the enrolment into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start11 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Invasive CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Motol
- Responsible party
- Sponsor
- Investigators
- Hana Slepčanová, Mgr., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456151
- Sponsor's protocol ID
- ULM-01-Invasive candidiasis
- Other IDs
- 03/RVO-FNOs/2024, SGS06/LF/2024
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Publications
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.
PubMed 35330311Bassetti 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.
PubMed 31585478
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Candidiasis in Critical Care
- ClinicalTrials.gov ID
- NCT06456151
- Acronym / sponsor ID
- ULM-01-Invasive candidiasis
- Conditions
- Invasive Candidiasis
- Keywords
- invasive candidiasis, biomarkers, candida sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University Hospital, Motol
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected invasive candidiasis | – | Diagnostic Test: Invasive candidiasis test, Other: Urine sample collection for future researchPatients with suspected invasive candidiasis will be enrolled in this study arm. |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected invasive candidasis.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive candidiasis testThe combination of acute phase marker monitoring and the T2Candida assay will be assessed. | Diagnostic test | Patients with suspected invasive candidiasis |
| Urine sample collection for future researchPatients will be asked to provide a urine sample for future research (urine biobank). | Other | Patients with suspected invasive candidiasis |
Primary outcome
Acute-phase biomarkers dynamics - procalcitonin
Time frame: 8 days
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.
Acute-phase biomarkers dynamics - interleukin-6
Time frame: 8 days
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.
Acute-phase biomarkers dynamics - interleukin-10
Time frame: 8 days
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.
Acute-phase biomarkers dynamics - Presepsin
Time frame: 8 days
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.
Acute-phase biomarkers dynamics - C-reactive protein
Time frame: 8 days
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.
Acute-phase biomarkers dynamics - 1,3-β-D-glucan
Time frame: 8 days
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.
Acute-phase biomarkers dynamics - pentraxin 3
Time frame: 8 days
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.
T2Candida test
Time frame: One-time measurement at the enrolment into the study
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.
Lipopolysaccharide binding protein
Time frame: One-time measurement at the enrolment into the study
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 35330311Dobias 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.
- Background: PubMed 31585478Bassetti 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.
- World Health Organisation (WHO) fungal priority pathogens list to guide research, development and public health actionLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hana Slepčanová, Mgr. principal investigator
University Hospital Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Candidiasis, run by University Hospital Ostrava at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute-phase biomarkers dynamics - procalcitonin (time frame: 8 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456151, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.