Suivi Prospectif Des ostéomyélites de la Base du crâne
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Malignant External Otitis (Necrotizing/Malignant Otitis Externa), Central Skull Base Osteomyelitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Primary outcome measures
- One-year prognosis of skull base osteomyelitis [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Lariboisière Hospital, 2 rue Ambroise Paré — Paris
Identifiers
NCT: NCT07665866 · APHP251672