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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT06329518
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Receiving venovenous or venoarterial ECMO support.
Exclusion Criteria:
* Females who are pregnant or breast-feeding
* History of any moderate or severe hypersensitivity or allergic reaction to any echinocandin antifungal
* Receiving rezafungin to treat documented or suspected infection within 14 days of screening, or expected to receive rezafungin during the study intervention phase
* Receiving or likely to require intermittent hemodialysis
* A hemoglobin less than 7.2 gm/dl at baseline
* Acute liver injury, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal, or AST or ALT \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal
* Patients expected to have ECMO discontinued within the next 24 hours
* Any rapidly progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
* Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06329518
Study Brief:
Protocol Section:
NCT06329518