Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-01 @ 1:03 AM
Study NCT ID:
NCT02226705
Status:
TERMINATED
Last Update Posted:
2021-04-09
First Post:
2014-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Surgical Treatment of Rhino-Sinusal Mucormycosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Endoscopic surgical treatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'End of inclusion period', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-08', 'studyFirstSubmitDate': '2014-07-25', 'studyFirstSubmitQcDate': '2014-08-25', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local control rate and survival rate', 'timeFrame': '3 months', 'description': 'To evaluate the local control rate and survival rate at 3 months after radical endoscopic transnasal surgery extended towards the skull base in association with antifungal therapy and early surgical reevaluation of the extent of the disease.'}], 'secondaryOutcomes': [{'measure': 'Survival rates', 'timeFrame': '6 and 12 months', 'description': 'Survival rates at 6 and 12 months'}, {'measure': 'Study of the response rate', 'timeFrame': '1 and 3 months', 'description': 'Study of the response rate at 1 and 3 months according to Segar criteria (Segal, Clin Infect Dis) using clinical, mycological and radiological evaluation.'}, {'measure': 'Study of the local control', 'timeFrame': '3 months', 'description': 'Study of the local control obtained at day 7+/-5 days and survival rate and response rate at 3 months.'}, {'measure': 'Study of the association between local control and survival rate and response rate', 'timeFrame': '3 months', 'description': 'Study of the association between local control obtained at 1 month and survival rate and response rate at 3 months.'}, {'measure': 'Evaluation of the interest of CT PET scan', 'timeFrame': '3 months', 'description': 'Evaluation of the interest of CT PET scan in studying clinical response at 3 months.'}, {'measure': 'Radiological staging', 'timeFrame': '3 months', 'description': 'Radiological staging: comparison of the initial extent of the mucormycosis at day 0 by CT scan and MRI and survival rate at 3 months and local control obtained at day 7.'}, {'measure': 'Dosage of the amphotericin B concentration inside tissues', 'timeFrame': 'Day 7', 'description': 'Dosage of the amphotericin B concentration inside tissues (infeusingcted and at the border of infected tissues) as obtained with biopsies at day 7.'}, {'measure': 'Search for biofilms using confocal microscopy', 'timeFrame': 'Day 0 and Day 7', 'description': 'Search for biofilms using confocal microscopy on infected tissues biopsies'}, {'measure': 'Staging of sequellae', 'timeFrame': '3 months, 6 months and 1 year', 'description': 'Staging of sequellae using quality of life questionnaires'}, {'measure': 'Bank of mucormycosis tissues', 'timeFrame': 'Day 0, Day 7, Day 14, D21 and Day 28', 'description': 'Bank of mucormycosis tissues at -80°C'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rhinocerebral Mucormycosis', 'Surgery', 'Fungal Infection', 'Survival'], 'conditions': ['Rhinocerebral Mucormycosis']}, 'descriptionModule': {'briefSummary': '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 of this study is to evaluate the local control rate and survival rate at 3 months after radical endoscopic transnasal surgery extended towards the skull base in association with antifungal therapy and early surgical reevaluation of the extent of the disease.', 'detailedDescription': '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, first clinical presentation is a common infection of the sinuses which can extend towards deep spaces of the face, orbits, the skull base and the brain. The mortality rates range from 20 to 50%, up to 80% in case of cerebral extension. through Transnasal Endoscopic Surgery extended to the Skull Base.\n\nHypothesis : We hypothesize that infected tissues are devascularized and because of that antifungal therapies can hardly reach areas of infected tissues. Radical endoscopic transnasal surgery associated with medical treatment with liposomal amphotericine B may increase the local control of the disease and the survival rate. Clinical evaluation of the extent of the disease within the first 7 days following initial surgery may represent a prognosis factor.\n\nMethods :\n\nFirst national mutlicentric and multidisciplinary cohort on Rhino-Sinusal Mucormycosis Radiological staging for evaluation of the extent of the disease using CT scan, MRI and PET Scan at initial stage before surgery Radical surgery and/or endoscopic transnasal surgery extended towards the skull base associated with liposomal amphotericine B medical treatment.\n\nAt day 7 new radiological evaluation and second surgical look to adapt surgical resection of infected tissues, perform biopsies to search for mycormycosis, biofilms and dosage of the concentration of liposomal amphotericin B inside tissues. New radiological and surgical looks in case of absence of local control obtained on the second look and further.\n\nStudy of the response rate by an endoscopic \\& scan follow-up (with biopsies for anatomopathological et mycological studies) at 1 month, 3 months, 6 months \\& one year. PET scan initially \\& at 3 months.\n\nNumber of subjects included : Phase II type trial (exclusion of a zero hypothesis of survival rate \\<50% ), N= 23 patients\n\nTotal length of the study 4 years Inclusion period time : 3 years Time of participation per patient : 1 year Number of center and/or participating departments: 24 Mean number of patients included per year and per center : 0 to 3 patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Patient treated by liposomal amphotericin B or just before being treated\n* Signature of informed consent :\n\n * by the patient if he is able to express their will\n * by the family or close, if the patient is unable to consent\n* Inclusion in emergency clause is possible ( CPP agreement ) if the patient is incapacitated , no close is present and that the surgery is urgent\n* Person affiliated to a Health Security System (beneficiary)\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding\n* Disseminated Mucormycosis (involvment of one site distant from the head and neck)\n* Known hypersensitivity to a polyene\n* Absence of documentation of mucormycosis (histological, mycological)\n* Contraindication to the completion of the surgery as provided in this protocol\n* Patient is the subject of a guardianship or tutelage measure'}, 'identificationModule': {'nctId': 'NCT02226705', 'acronym': 'MICCA', 'briefTitle': 'Endoscopic Surgical Treatment of Rhino-Sinusal Mucormycosis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Treatment of Rhino-Sinusal Mucormycosis Through Transnasal Endoscopic Surgery Extended to the Skull Base.', 'orgStudyIdInfo': {'id': 'P110151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multiple Surgeries', 'description': 'Patients undergoing transnasal endoscopic surgery', 'interventionNames': ['Procedure: Multiple transnasal endoscopic surgeries']}], 'interventions': [{'name': 'Multiple transnasal endoscopic surgeries', 'type': 'PROCEDURE', 'description': 'Transnasal endoscopic surgery extended to the skull base', 'armGroupLabels': ['Multiple Surgeries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Romain KANIA, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}