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Suivi Prospectif Des ostéomyélites de la Base du crâne

Suivi Prospectif Des ostéomyélites de la Base du crâne

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07665866
Acronym
OBC
Enrollment
100
Registered
2026-06-24
Start date
2026-08-01
Completion date
2029-07-31
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Skull Base Osteomyelitis (SBO), Osteomyelitis of the Skull Base, Malignant External Otitis, Skull Base Infection, Infectious Diseases

Brief 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.

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).

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
One-year prognosis of skull base osteomyelitis1 yearassessed by the occurrence of recurrence, relapse, and all-cause mortality within 12 months after diagnosis. Time Frame: 12 months.

Countries

France

Contacts

CONTACTMunier Anne-Lise, PH
anne-lise.munier@aphp.fr0149956339

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026