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NCT Number: NCT07665866

Suivi Prospectif Des ostéomyélites de la Base du crâne

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.

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Key information

Conditions

Malignant External Otitis (Necrotizing/Malignant Otitis Externa) Central Skull Base Osteomyelitis Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lariboisière Hospital, 2 rue Ambroise Paré

Paris, 75010, France

Location contact

Anne-Lise Munier, ph

CONTACT

[email protected]

0149956339

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Munier Anne-Lise, PH

CONTACT

[email protected]

0149956339

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: OBC

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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