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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT00606268
Eligibility Criteria:
Inclusion Criteria:
* Institutional Review Board (IRB)-approved written informed Consent / Assent (as applicable) and HIPAA Authorization must be obtained from the subject (as able) and /or subject's parent/legally authorized representative prior to any study-related procedures
* Subject has sufficient venous access to permit administration of study drug, collect pharmacokinetic samples and monitor laboratory safety variables
* Female subject of childbearing potential must have a negative pregnancy test within 72 hours prior to the first dose of study drug, and if sexually active agree method of birth control per Investigator judgment for the duration of the study
* Subject (when able) and /or subjects parent/legally authorized representative agree to comply with the study requirements and with the concomitant medication restrictions
* Subject plans to undergo a HSCT
Exclusion Criteria:
* Subject has evidence of significant liver disease as defined by aspartate transamine (AST/SGOT), alanine transaminases (ALT/SGPT) 10 times the upper limit of normal (ULN) and total bilirubin or alkaline phosphatase \> 5 times the ULN
* Subject has concomitant medical condition that in the opinion of the Investigator and /or medical monitor precludes enrollment into the study
* Subject with evidence of an active systemic or disseminated fungal infection prior to enrollment
* Subject has a history of anaphylaxis, hypersensitivity, or any serious reactions to the echinocandin class of antifungals
* Subject had received treatment with an echinocandin within one week prior to first dose of study drug
* Subject status is unstable and subject is unlikely to complete required study procedures
* Female subject is pregnant or nursing. Females of childbearing potential must avoid becoming pregnant while receiving study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Months
Maximum Age:
16 Years
Study:
NCT00606268
Study Brief:
Protocol Section:
NCT00606268