Rhinocerebral MucormycosisMICCANCT02226705
Endoscopic Surgical Treatment of Rhino-Sinusal Mucormycosis
A study testing Multiple transnasal endoscopic surgeries in people with Rhinocerebral Mucormycosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinocerebral Mucormycosis
- What is being tested?
- Multiple transnasal endoscopic surgeries
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Rhino-Sinusal Mucormycosis Through Transnasal Endoscopic Surgery Extended to the Skull Base.
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.
Read the 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
- Conditions
- Rhinocerebral Mucormycosis
- Being tested
- Multiple transnasal endoscopic surgeries
- Keywords
- Rhinocerebral Mucormycosis, Surgery, Fungal Infection, Survival
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple transnasal endoscopic surgeriesProcedure or surgery
Transnasal endoscopic surgery extended to the skull base
| Study group | Role | What they receive |
|---|---|---|
| Multiple Surgeries | Experimental | Patients undergoing transnasal endoscopic surgery Receives: Procedure: Multiple transnasal endoscopic surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate and survival rate
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.
Measured: 3 months
Secondary outcomes (10)
Survival rates
Survival rates at 6 and 12 months
Measured: 6 and 12 months
Study of the response rate
Study of the response rate at 1 and 3 months according to Segar criteria (Segal, Clin Infect Dis) using clinical, mycological and radiological evaluation.
Measured: 1 and 3 months
Study of the local control
Study of the local control obtained at day 7+/-5 days and survival rate and response rate at 3 months.
Measured: 3 months
Study of the association between local control and survival rate and response rate
Study of the association between local control obtained at 1 month and survival rate and response rate at 3 months.
Measured: 3 months
Evaluation of the interest of CT PET scan
Evaluation of the interest of CT PET scan in studying clinical response at 3 months.
Measured: 3 months
Radiological staging
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.
Measured: 3 months
Dosage of the amphotericin B concentration inside tissues
Dosage of the amphotericin B concentration inside tissues (infeusingcted and at the border of infected tissues) as obtained with biopsies at day 7.
Measured: Day 7
Search for biofilms using confocal microscopy
Search for biofilms using confocal microscopy on infected tissues biopsies
Measured: Day 0 and Day 7
Staging of sequellae
Staging of sequellae using quality of life questionnaires
Measured: 3 months, 6 months and 1 year
Bank of mucormycosis tissues
Bank of mucormycosis tissues at -80°C
Measured: Day 0, Day 7, Day 14, D21 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2018
- Study completionJan 2021
Why it stopped: End of inclusion period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinocerebral MucormycosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Endoscopic surgical treatment
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain KANIA, PhD, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226705
- Sponsor's protocol ID
- P110151
- Acronym
- MICCA
- Status last verified
- Apr 2021
- First submitted
- 25 Jul 2014
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Rhino-Sinusal Mucormycosis Through Transnasal Endoscopic Surgery Extended to the Skull Base.
- ClinicalTrials.gov ID
- NCT02226705
- Acronym / sponsor ID
- MICCA / P110151
- Conditions
- Rhinocerebral Mucormycosis
- Keywords
- Rhinocerebral Mucormycosis, Surgery, Fungal Infection, Survival
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of inclusion period
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Endoscopic surgical treatment
| Arm | Type | Receives |
|---|---|---|
| Multiple Surgeries | Experimental | Procedure: Multiple transnasal endoscopic surgeriesPatients undergoing transnasal endoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 :
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple transnasal endoscopic surgeriesTransnasal endoscopic surgery extended to the skull base | Procedure or surgery | Multiple Surgeries |
Primary outcome
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.
10 secondary outcomes
Survival rates
Time frame: 6 and 12 months
Study of the response rate
Time frame: 1 and 3 months
Study of the local control
Time frame: 3 months
Study of the association between local control and survival rate and response rate
Time frame: 3 months
Evaluation of the interest of CT PET scan
Time frame: 3 months
Radiological staging
Time frame: 3 months
Dosage of the amphotericin B concentration inside tissues
Time frame: Day 7
Search for biofilms using confocal microscopy
Time frame: Day 0 and Day 7
Staging of sequellae
Time frame: 3 months, 6 months and 1 year
Bank of mucormycosis tissues
Time frame: Day 0, Day 7, Day 14, D21 and Day 28
Results and safety
The study was stopped early (reason given: End of inclusion period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain KANIA, PhD, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple transnasal endoscopic surgeries in people with Rhinocerebral Mucormycosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: End of inclusion period). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control rate and survival rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.