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Clinical Trials in France / NCT07665866
Starting soon Observational

Suivi Prospectif Des ostéomyélites de la Base du crâne

NCT07665866 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2026-08-01
Last updated
2026-06-24

Condition(s) studied

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • One-year prognosis of skull base osteomyelitis — 1 year
    assessed by the occurrence of recurrence, relapse, and all-cause mortality within 12 months after diagnosis. Time Frame: 12 months.

Trial sites (1)

FacilityCityRegionStatus
Lariboisière Hospital, 2 rue Ambroise Paré Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07665866 on ClinicalTrials.gov ↗ ← All trials in France