Invasive Candidiasis in Critical Care

Recruiting

• Conditions: Invasive Candidiasis
• Interventions: Diagnostic Test: Invasive candidiasis test; Other: Urine sample collection for future research

• Registration Number: NCT06456151
• Lead Sponsor: University Hospital Ostrava

Brief 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.

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 Timeline

• Study Start: 2024-04-11
• Status Verified: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with suspected invasive candidiasis	Invasive candidiasis test	Patients with suspected invasive candidiasis will be enrolled in this study arm.
Patients with suspected invasive candidiasis	Urine sample collection for future research	Patients with suspected invasive candidiasis will be enrolled in this study arm.

Primary Outcome Measures

Name	Time	Method
Acute-phase biomarkers dynamics - interleukin-10	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 - pentraxin 3	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.
Lipopolysaccharide binding protein	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.
Acute-phase biomarkers dynamics - 1,3-β-D-glucan	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 - Presepsin	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 - procalcitonin	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	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 - C-reactive protein	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.
T2Candida test	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.

Trial Locations

Locations (2)

University Hospital Motol; 🇨🇿 Prague, Czechia

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia