Invasive Candidiasis in Critical Care

Invasive Candidiasis Clinical Trial

Official title:

Invasive Candidiasis in Critical Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06456151
• Other study ID #: ULM-01-Invasive candidiasis
• Secondary ID: 03/RVO-FNOs/2024
• Status: Recruiting
• Start date: April 11, 2024
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: University Hospital Ostrava
• Contact: Jirí Hyncica
• Phone: 0042059737
• Email: jiri.hyncica[@]fno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical 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 candidiasis and candidemia in ICU patients, thereby improving the clinical condition of patients and reducing the cost of specific antifungal therapy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiasis

Intervention

Diagnostic Test:
• Invasive candidiasis test
The combination of acute phase marker monitoring and the T2Candida assay will be assessed.

Other:
• Urine sample collection for future research
Patients will be asked to provide a urine sample for future research (urine biobank).

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region
Czechia	University Hospital Motol	Prague

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Ostrava	University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Acute-phase biomarkers dynamics - 1,3-ß-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
Primary	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
Primary	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
Primary	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

External Links

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