Status:
TERMINATED
Endoscopic Surgical Treatment of Rhino-Sinusal Mucormycosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Rhinocerebral Mucormycosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Radical endoscopic transnasal surgery associated with medical treatment with liposomal amphotericine B may increase the local control of Rhino-Sinusal Mucormycosis and the survival rate. The objective...
Detailed Description
Introduction : Treatment of Rhino-Sinusal Mucormycosis remains a challenge because of the severity of the disease with high mortality rates. Mainly involving diabetic and immunodeficient patients, fir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02226705
Start Date
January 1 2015
End Date
January 1 2021
Last Update
April 9 2021
Active Locations (1)
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1
Hôpital Lariboisière
Paris, France, 75010