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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT03121235
Eligibility Criteria:
Inclusion Criteria:
* Patient with underlying hematological disease
* Patient will undergo/underwent BAL sampling for suspected invasive fungal infection
* BAL samples should be submitted to the local microbiology lab for fungal culture and for galactomannan detection.
* The treating physician is planning to start voriconazole, isavuconazole or posaconazole after the BAL has been sampled while waiting for the culture or PCR results of the BAL sample or has already started voriconazole or posaconazole before BAL sampling.
Exclusion Criteria:
* A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Antifungal therapy was started \>120hours prior to BAL sampling (\*)
* Antifungal prophylaxis with posaconazole or voriconazole for \>5 days within the 2 weeks preceding BAL sampling
* Antifungal prophylaxis with itraconazole and at least half of the plasma itraconazole/hydroxy-itraconazole levels that were measured through therapeutic drug monitoring were above the minimum effective plasma concentration of 0.5mg/L (parental compound only, HLPC assay method). The minimum effective plasma concentration of 0.5mg/L for itraconazole has been established by the ECIL 6 meeting with a recommendation AII.
(\*) Patients that develop new pulmonary infiltrates during antifungal prophylaxis (systemic azoles or aerosolized amphotericin B) can be included.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03121235
Study Brief:
Protocol Section:
NCT03121235