Endoscopic Surgical Treatment of Rhino-Sinusal Mucormycosis (MICCA)
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|ClinicalTrials.gov Identifier: NCT02226705|
Recruitment Status : Recruiting
First Posted : August 27, 2014
Last Update Posted : August 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rhinocerebral Mucormycosis||Procedure: Multiple transnasal endoscopic surgeries||Phase 2|
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.
Hypothesis : 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.
First 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.
At 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.
Study 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.
Number of subjects included : Phase II type trial (exclusion of a zero hypothesis of survival rate <50% ), N= 23 patients
Total 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Rhino-Sinusal Mucormycosis Through Transnasal Endoscopic Surgery Extended to the Skull Base.|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Multiple Surgeries
Patients undergoing transnasal endoscopic surgery
Procedure: Multiple transnasal endoscopic surgeries
Transnasal endoscopic surgery extended to the skull base
- Local control rate and survival rate [ Time Frame: 3 months ]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.
- Survival rates [ Time Frame: 6 and 12 months ]Survival rates at 6 and 12 months
- Study of the response rate [ Time Frame: 1 and 3 months ]Study of the response rate at 1 and 3 months according to Segar criteria (Segal, Clin Infect Dis) using clinical, mycological and radiological evaluation.
- Study of the local control [ Time Frame: 3 months ]Study of the local control obtained at day 7+/-5 days and survival rate and response rate at 3 months.
- Study of the association between local control and survival rate and response rate [ Time Frame: 3 months ]Study of the association between local control obtained at 1 month and survival rate and response rate at 3 months.
- Evaluation of the interest of CT PET scan [ Time Frame: 3 months ]Evaluation of the interest of CT PET scan in studying clinical response at 3 months.
- Radiological staging [ Time Frame: 3 months ]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.
- Dosage of the amphotericin B concentration inside tissues [ Time Frame: Day 7 ]Dosage of the amphotericin B concentration inside tissues (infeusingcted and at the border of infected tissues) as obtained with biopsies at day 7.
- Search for biofilms using confocal microscopy [ Time Frame: Day 0 and Day 7 ]Search for biofilms using confocal microscopy on infected tissues biopsies
- Staging of sequellae [ Time Frame: 3 months, 6 months and 1 year ]Staging of sequellae using quality of life questionnaires
- Bank of mucormycosis tissues [ Time Frame: Day 0, Day 7, Day 14, D21 and Day 28 ]Bank of mucormycosis tissues at -80°C
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226705
|Contact: Cecile KEDZIA||+33(0) 1 44 84 17 email@example.com|
|Paris, France, 75010|
|Contact: Romain KANIA, PhD, MD 01 49 95 80 57 firstname.lastname@example.org|
|Principal Investigator: Romain KANIA, PhD, MD|
|Principal Investigator:||Romain KANIA, PhD, MD||Assistance Publique - Hôpitaux de Paris|