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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 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.

Condition or disease Intervention/treatment Phase
Rhinocerebral Mucormycosis Procedure: Multiple transnasal endoscopic surgeries Phase 2

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, 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.

Methods :

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Multiple Surgeries
Patients undergoing transnasal endoscopic surgery
Procedure: Multiple transnasal endoscopic surgeries
Transnasal endoscopic surgery extended to the skull base



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Survival rates [ Time Frame: 6 and 12 months ]
    Survival rates at 6 and 12 months

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  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.

  8. Search for biofilms using confocal microscopy [ Time Frame: Day 0 and Day 7 ]
    Search for biofilms using confocal microscopy on infected tissues biopsies

  9. Staging of sequellae [ Time Frame: 3 months, 6 months and 1 year ]
    Staging of sequellae using quality of life questionnaires

  10. Bank of mucormycosis tissues [ Time Frame: Day 0, Day 7, Day 14, D21 and Day 28 ]
    Bank of mucormycosis tissues at -80°C



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Cecile KEDZIA +33(0) 1 44 84 17 33 cecile.kedzia@sls.aphp.fr

Locations
France
Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Romain KANIA, PhD, MD    01 49 95 80 57    romain.kania@lrb.aphp.fr   
Principal Investigator: Romain KANIA, PhD, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Romain KANIA, PhD, MD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02226705     History of Changes
Other Study ID Numbers: P110151
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rhinocerebral Mucormycosis
Surgery
Fungal Infection
Survival

Additional relevant MeSH terms:
Mucormycosis
Zygomycosis
Mycoses