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Not Yet Recruiting NCT07665866

Suivi Prospectif Des ostéomyélites de la Base du crâne

Conditions: Malignant External Otitis (Necrotizing/Malignant Otitis Externa), Central Skull Base Osteomyelitis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Assistance Publique - Hôpitaux de Paris

Location: Lariboisière Hospital, 2 rue Ambroise Paré Paris

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. 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.

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07665866). StuddyBuddy aggregates publicly available trial information.