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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT01169402
Eligibility Criteria:
Inclusion Criteria:
1. \<= 17.5 years at the time of enrollment.
2. Sufficient venous access to permit administration of study medication.
3. Supported with either venoarterial (VA) or venovenous (VV) ECMO.
4. Availability and willingness of the parent/legal guardian to provide written informed consent.
Exclusion Criteria:
1. Subject with a history of anaphylaxis attributed to an azole.
2. Any other concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
3. Previous participation in this study.
4. Subjects who are receiving or who have received cyclosporine, tacrolimus, or azithromycin in the 72 hours prior to first dose of study product require protocol chair notification prior to enrollment.
5. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT01169402
Study Brief:
Protocol Section:
NCT01169402