Malignant External Otitis (Necrotizing/Malignant Otitis Externa)OBCNCT07665866
Suivi Prospectif Des ostéomyélites de la Base du crâne
An observational study of Malignant External Otitis (Necrotizing/Malignant Otitis Externa) and Central Skull Base Osteomyelitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Skull base osteomyelitis (SBO) is a rare and complex infection that includes malignant external otitis and central skull base osteomyelitis. Symptoms are often non-specific, and the disease typically progresses slowly, leading to delays in diagnosis and treatment, as well as local or regional complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant External Otitis (Necrotizing/Malignant Otitis Externa), Central Skull Base Osteomyelitis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2026to 31 Jul 2029
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients aged 18 years or older diagnosed with skull base osteomyelitis (see definition below) during outpatient consultation or hospitalization at Lariboisière Hospital will be eligible for inclusion in the study, provided that they do not object to participation.
Who may be able to join
- Participants must meet all of the following criteria:
- Age ≥ 18 years.
- Diagnosis of skull base osteomyelitis, based on the combination of:
- Clinical signs: otorrhea and/or otalgia and/or granulation tissue in the external -auditory canal, headache(s) and/or paralysis of one or more cranial nerves;
- AND radiological findings: bone destruction/osteolysis demonstrated on CT scan and/or MRI.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Expressed refusal (objection) to participate in the study. Individuals under legal protection measures (guardianship, curatorship, or judicial protection).
- Patients managed for osteoradionecrosis. Patients managed for squamous cell carcinoma of the external auditory canal.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Lariboisière Hospital, 2 rue Ambroise Paré
Paris, 75010
Anne-Lise Munier, ph, 0149956339, anne-lise.munier@aphp.fr
About this study
Skull base osteomyelitis (SBO) is a rare and complex infection that includes malignant external otitis and central skull base osteomyelitis.
Symptoms are often non-specific, and the disease typically progresses slowly, leading to delays in diagnosis and treatment, as well as local or regional complications.
Read more
Management is not standardized and consists of medical treatment tailored to microbiological sampling results (antibiotic or antifungal therapy). Monitoring strategies and treatment modalities, particularly treatment duration, have not been standardized.
Given the rarity of these infections, it is currently very difficult to conduct prospective studies comparing different management approaches.
Read the detailed description
This will be a prospective multicenter study involving departments of Otorhinolaryngology (ENT), Infectious Diseases, Diabetology, and Internal Medicine.
Patients receiving care for skull base osteomyelitis who are seen either in outpatient consultation or during hospitalization will be included in the study, provided that their non-objection to participation has been obtained.
Patients will be managed and monitored according to standard clinical practice (routine care).
- Conditions
- Malignant External Otitis (Necrotizing/Malignant Otitis Externa), Central Skull Base Osteomyelitis
- Keywords
- Skull Base Osteomyelitis (SBO), Osteomyelitis of the Skull Base, Malignant External Otitis, Skull Base Infection, Infectious Diseases
- Medical subject headings
- Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year prognosis of skull base osteomyelitis
assessed by the occurrence of recurrence, relapse, and all-cause mortality within 12 months after diagnosis. Time Frame: 12 months.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant External Otitis (Necrotizing/Malignant Otitis Externa)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665866
- Sponsor's protocol ID
- APHP251672
- Acronym
- OBC
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suivi Prospectif Des ostéomyélites de la Base du crâne
- ClinicalTrials.gov ID
- NCT07665866
- Acronym / sponsor ID
- OBC / APHP251672
- Conditions
- Malignant External Otitis (Necrotizing/Malignant Otitis Externa), Central Skull Base Osteomyelitis
- Keywords
- Skull Base Osteomyelitis (SBO), Osteomyelitis of the Skull Base, Malignant External Otitis, Skull Base Infection, Infectious Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 24 Jun 2026 (actual)
- 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.
Skull base osteomyelitis (SBO) is a rare and complex infection that includes malignant external otitis and central skull base osteomyelitis.
Symptoms are often non-specific, and the disease typically progresses slowly, leading to delays in diagnosis and treatment, as well as local or regional complications.
Management is not standardized and consists of medical treatment tailored to microbiological sampling results (antibiotic or antifungal therapy). Monitoring strategies and treatment modalities, particularly treatment duration, have not been standardized.
Given the rarity of these infections, it is currently very difficult to conduct prospective studies comparing different management approaches.
Detailed description
This will be a prospective multicenter study involving departments of Otorhinolaryngology (ENT), Infectious Diseases, Diabetology, and Internal Medicine.
Patients receiving care for skull base osteomyelitis who are seen either in outpatient consultation or during hospitalization will be included in the study, provided that their non-objection to participation has been obtained.
Patients will be managed and monitored according to standard clinical practice (routine care).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18 years or older diagnosed with skull base osteomyelitis (see definition below) during outpatient consultation or hospitalization at Lariboisière Hospital will be eligible for inclusion in the study, provided that they do not object to participation.
Key inclusion criteria (5 listed)
- Participants must meet all of the following criteria:
- Age ≥ 18 years.
- Diagnosis of skull base osteomyelitis, based on the combination of:
- Clinical signs: otorrhea and/or otalgia and/or granulation tissue in the external -auditory canal, headache(s) and/or paralysis of one or more cranial nerves;
- AND radiological findings: bone destruction/osteolysis demonstrated on CT scan and/or MRI.
Key exclusion criteria (3 listed)
- Participants meeting any of the following criteria will be excluded:
- Expressed refusal (objection) to participate in the study. Individuals under legal protection measures (guardianship, curatorship, or judicial protection).
- Patients managed for osteoradionecrosis. Patients managed for squamous cell carcinoma of the external auditory canal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
One-year prognosis of skull base osteomyelitis
Time frame: 1 year
assessed by the occurrence of recurrence, relapse, and all-cause mortality within 12 months after diagnosis. Time Frame: 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant External Otitis (Necrotizing/Malignant Otitis Externa) and Central Skull Base Osteomyelitis, 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Munier Anne-Lise, PH (0149956339, anne-lise.munier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year prognosis of skull base osteomyelitis (time frame: 1 year). 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 24 Jun 2026.