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 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT00784368
Eligibility Criteria:
Inclusion Criteria:
* In case of participants with deep-seated mycosis (systemic fungal infection \[SFI\]) they should be either clinically suspected case or proven case
* All participants administered need to be hospitalized during the itraconazole intravenous treatment
* For participants with febrile (with fever) neutropenia (a decrease in white blood cells) suspected of fungal infection who have persistent fever (greater than equal to 37.5 degree celsius; greater than equal to 3 days) and have neutrophil count less than 500 per cubic millimeter (or less than 1000 per cubic millimeter and expected to decrease toward less than 500 per cubic millimeter
Exclusion Criteria:
* No past history of hypersensitivity to azole antifungal agents
* No current medication with antifungal agents such as amphotericin B (intravenous injection \[injection of a substance into a vein\], tablets, syrup), nystatin (tablets), fluconazole (capsules, intravenous injection), flucytosine (oral agent), miconazole (intravenous injection, gel), micafungin (intravenous infusion), fosfluconazole (intravenous injection,) voriconazole (intravenous injection, tablets), liposomal amphotericin B (intravenous injection), posaconazole
* No medication with itraconazole in any formulation within the last 28 days
* Participants with history of severe hepatic disease (except hepatic dysfunction because of fungal infection) and congestive heart failure
* Female participants who are either pregnant, nursing, suspected to be pregnant or will become pregnant during the trial duration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT00784368
Study Brief:
Protocol Section:
NCT00784368