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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT02226705
Eligibility Criteria:
Inclusion Criteria:
* Man or woman, over 18 years old, presenting a mucormycosis on a sinus biopsy showing large filaments with non or little septae compatible with a mucoral or with a positive culture for a mucoral on a sinus sample associated to clinical head \& neack anomalies (endoscopic) \& scans compatible with a mucormycosis previous to the inclusion and this whatever the patient incumbent pathology.
* Patient treated by liposomal amphotericin B or just before being treated
* Signature of informed consent :
* by the patient if he is able to express their will
* by the family or close, if the patient is unable to consent
* Inclusion in emergency clause is possible ( CPP agreement ) if the patient is incapacitated , no close is present and that the surgery is urgent
* Person affiliated to a Health Security System (beneficiary)
Exclusion Criteria:
* Pregnancy, breastfeeding
* Disseminated Mucormycosis (involvment of one site distant from the head and neck)
* Known hypersensitivity to a polyene
* Absence of documentation of mucormycosis (histological, mycological)
* Contraindication to the completion of the surgery as provided in this protocol
* Patient is the subject of a guardianship or tutelage measure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02226705
Study Brief:
Protocol Section:
NCT02226705