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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT01383993
Eligibility Criteria:
Inclusion Criteria:
* Male or female from 2 to \<15 years of age.
* Require treatment for the prevention of systemic fungal infection.
* Expected to develop neutropenia (ANC \<500 cells/uL) lasting more than 10 days following chemotherapy.
* Anticipated to live for more than 3 months.
Exclusion Criteria:
* Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.
* Documented bacterial or viral infection not responding to appropriate treatment.
* Hypersensitivity to or severe intolerance of azole antifungal agents.
* Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
15 Years
Study:
NCT01383993
Study Brief:
Protocol Section:
NCT01383993