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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT02621905
Eligibility Criteria:
Inclusion Criteria:
* Provision of written, informed consent
* Age of at least 18 years
* No clinical evidence of active systemic fungal infection
* Physician-recommended primary prophylaxis against systemic fungal infections with itraconazole in patients who have had or about to have: a heart, lung or bone marrow transplant, combination chemotherapy for cancer; aspergilloma, chronic pulmonary aspergillus bronchitis, or allergic bronchopulmonary aspergillosis
* Patients may be receiving itraconazole prophylaxis prior to entry into the study
* Body mass index between 15.0 and 35.0 kg/m2
Exclusion Criteria:
* Pregnant, planning pregnancy or breastfeeding
* Congestive cardiac failure or other causes of ventricular dysfunction that may outweigh the benefit of itraconazole
* Hypersensitivity to either study drug or to any of their excipients
* Coadministration of the following drugs:
* CYP3A4 metabolised substrates that can prolong the QT-interval e.g., sertindole, terfenadine
* CYP3A4 metabolised HMG-CoA reductase inhibitors e.g. simvastatin, lovastatin
* Potent CYP3A4 inhibitors e.g. dronedarone
* Triazolam, alprazolam and oral midazolam
* Ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine) and ergotamine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02621905
Study Brief:
Protocol Section:
NCT02621905