Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT06456151
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Study:
NCT06456151
Study Brief:
Protocol Section:
NCT06456151