Suivi Prospectif Des ostéomyélites de la Base du crâne (OBC)

June 18, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

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).

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75010
        • Lariboisière Hospital, 2 rue Ambroise Paré
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients aged 18 years or older diagnosed with skull base osteomyelitis (see definition below) during outpatient consultation or hospitalization at Lariboisière Hospital will be eligible for inclusion in the study, provided that they do not object to participation.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP251672

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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