Acute MastoiditisMAGENCT07122440
Outcomes and Prognostic Factors of Acute Mastoiditis in the Grand-Est Region
An observational study of Acute Mastoiditis, run by Cécile RUMEAU at 1 site in France.
Trial summary
There is an increased incidence of acute mastoïditis and a lack of homogeneity in management. The investigator aim to refine the epidemiological knowledge on this pathology. Data of children with acute mastoiditis of the last ten years in five hospitals of the North-East of France (University Hospitals of Nancy… Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Acute Mastoiditis
- What is being tested?
- acute mastoiditis
- How many people
- 326 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2024to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Cf Eligibility criteria
Who may be able to join
- All patients under 15 years of age
- Supported in one of the ENT or pediatric services of the four investigation centers
- Between January 1, 2014 and July 31, 2024
- With a diagnosis of acute mastoiditis
Who cannot join
- Patient with history of cholesteatoma or cochlear implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Évaluation Des Facteurs Pronostiques et de l'évolution Des mastoïdites aigües Dans la région Grand-Est
There is an increased incidence of acute mastoïditis and a lack of homogeneity in management. The investigator aim to refine the epidemiological knowledge on this pathology.
Data of children with acute mastoiditis of the last ten years in five hospitals of the North-East of France (University Hospitals of Nancy, Strasbourg, Dijon, Besançon and the Regional Hospital of Metz-Thionville) will be analyzed.
Read the detailed description
Acute mastoiditis is a bacterial infection of the middle ear cavities, associated with destructive damage of the mastoid bone, complicating acute otitis media. It affects infants and young children and its complications can be serious, including neurological sequelae.
These complications can be divided into two categories according to their topography:
- intracranial complications : thrombophlebitis, meningitis, epidural abscess, and cerebral empyema.
- Extracranial complications subperiosteal abscess, Bezold's abscess, peripheral facial paralysis, labyrinthitis, and temporomandibular joint arthritis.
Incidence ranges from 1.2 to 6 per 100,000 children per year, with a trend of increasing cases with the increase in the proportion of Fusobacterium Necrophorum infections, described as frequent provider of complications. This observation is shared by the ENT practitioners of the CHRU of Nancy.
The management of mastoiditis is medico-surgical, but the therapeutic algorithms vary according to the centers and countries. The exact place of surgery is discussed in uncomplicated cases, despite recent meta-analyses. In France, no therapeutic algorithm is currently proposed by ENT societies.
Given this double observation of increased incidence and lack of homogeneity in the management of mastoiditis, it appears to be useful to refine the epidemiological knowledge on this pathology.
Therefore, we will analyze data of children with acute mastoiditis of the last ten years in five hospitals of the North-East of France : University Hospitals of Nancy, Strasbourg, Dijon, Besançon and the Regional Hospital of Metz-Thionville.
- Conditions
- Acute Mastoiditis
- Being tested
- acute mastoiditis
- Keywords
- acute mastoiditis, prognostic, mastoiditis complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute mastoiditisOther
retrospective data collection from clinical charts
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic factors of recovery in children hospitalized for mastoiditis in the region Grand-Est of France between 2014 and 2024
The primary outcome was recovery by Day 5, i.e., recovery on the fifth day of hospitalization.
Recovery was a composite outcome based on three subcriteria:
- (i) absence of fever (body temperature ≥ 38°C);
- AND (ii) absence of neutrophilia (neutrophil count > 8.5 G/L);
- AND (iii) absence of local symptoms (i.e., otalgia or ear inflammation).
Patients presenting with fever OR neutrophilia OR local clinical symptoms on Day 5 or later were classified as not recovered by Day 5. Fever and local symptoms are monitored by the nursing staff several times a day during the hospitalization. The neutrophil count is measured as part of the laboratory test, performed on the day of hospital admission, and carried out multiple times during hospitalizations. The absence of follow-up laboratory testing suggests clinical improvement.
The abovementioned outcomes were extracted, as well as variables known or suspected to be associated with mastoiditis recovery or complications.
Measured: From January 2014 to July 2024
Secondary outcomes (2)
Evolution of complication rate of mastoiditis between January 2014 and July 2024
Intracranial complications were defined by the presence of thrombophlebitis, meningitis, epidural abscess, and cerebral empyema.
Extracranial complications included subperiosteal abscess, Bezold's abscess, peripheral facial paralysis, labyrinthitis, and temporomandibular joint arthritis.
Measured: From January 2014 to July 2024
Factors associated with complicated acute mastoïditis
Intracranial complications were defined by the presence of thrombophlebitis, meningitis, epidural abscess, and cerebral empyema.
Extracranial complications included subperiosteal abscess, Bezold's abscess, peripheral facial paralysis, labyrinthitis, and temporomandibular joint arthritis.
The abovementioned outcomes were extracted, as well as variables known or suspected to be associated with mastoiditis recovery or complications. These variables were patients' demographic characteristics (age, gender, hospital center), medical history (prematurity, surgery), pre-hospital care (delay between symptom onset and hospitalization, antibiotic treatment before admission), medical care during the hospitalization (surgery, anti-inflammatory treatment, empirical and targeted antibiotic therapy), biological results (date of laboratory tests, C-reactive protein, leucocytes, neutrophils), bacteriological results (date and type of specimen, bacteria identified).
Measured: From January 2014 to July 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start2 Mar 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MastoiditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cécile RUMEAU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cécile RUMEAU, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122440
- Sponsor's protocol ID
- 2023PI213
- Acronym
- MAGE
- Status last verified
- Aug 2025
- First submitted
- 3 Jan 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Évaluation Des Facteurs Pronostiques et de l'évolution Des mastoïdites aigües Dans la région Grand-Est
- ClinicalTrials.gov ID
- NCT07122440
- Acronym / sponsor ID
- MAGE / 2023PI213
- Conditions
- Acute Mastoiditis
- Keywords
- acute mastoiditis, prognostic, mastoiditis complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Cécile RUMEAUUniversity, hospital or other
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is an increased incidence of acute mastoïditis and a lack of homogeneity in management. The investigator aim to refine the epidemiological knowledge on this pathology.
Data of children with acute mastoiditis of the last ten years in five hospitals of the North-East of France (University Hospitals of Nancy, Strasbourg, Dijon, Besançon and the Regional Hospital of Metz-Thionville) will be analyzed.
Detailed description
Acute mastoiditis is a bacterial infection of the middle ear cavities, associated with destructive damage of the mastoid bone, complicating acute otitis media. It affects infants and young children and its complications can be serious, including neurological sequelae.
These complications can be divided into two categories according to their topography:
- intracranial complications : thrombophlebitis, meningitis, epidural abscess, and cerebral empyema.
- Extracranial complications subperiosteal abscess, Bezold's abscess, peripheral facial paralysis, labyrinthitis, and temporomandibular joint arthritis.
Incidence ranges from 1.2 to 6 per 100,000 children per year, with a trend of increasing cases with the increase in the proportion of Fusobacterium Necrophorum infections, described as frequent provider of complications. This observation is shared by the ENT practitioners of the CHRU of Nancy.
The management of mastoiditis is medico-surgical, but the therapeutic algorithms vary according to the centers and countries. The exact place of surgery is discussed in uncomplicated cases, despite recent meta-analyses. In France, no therapeutic algorithm is currently proposed by ENT societies.
Given this double observation of increased incidence and lack of homogeneity in the management of mastoiditis, it appears to be useful to refine the epidemiological knowledge on this pathology.
Therefore, we will analyze data of children with acute mastoiditis of the last ten years in five hospitals of the North-East of France : University Hospitals of Nancy, Strasbourg, Dijon, Besançon and the Regional Hospital of Metz-Thionville.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Cf Eligibility criteria
Key inclusion criteria (4 listed)
- All patients under 15 years of age
- Supported in one of the ENT or pediatric services of the four investigation centers
- Between January 1, 2014 and July 31, 2024
- With a diagnosis of acute mastoiditis
Key exclusion criteria (1 listed)
- Patient with history of cholesteatoma or cochlear implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acute mastoiditisretrospective data collection from clinical charts | Other | – |
Primary outcome
Prognostic factors of recovery in children hospitalized for mastoiditis in the region Grand-Est of France between 2014 and 2024
Time frame: From January 2014 to July 2024
The primary outcome was recovery by Day 5, i.e., recovery on the fifth day of hospitalization. Recovery was a composite outcome based on three subcriteria: * (i) absence of fever (body temperature ≥ 38°C); * AND (ii) absence of neutrophilia (neutrophil count > 8.5 G/L); * AND (iii) absence of local symptoms (i.e., otalgia or ear inflammation). Patients presenting with fever OR neutrophilia OR local clinical symptoms on Day 5 or later were classified as not recovered by Day 5. Fever and local symptoms are monitored by the nursing staff several times a day during the hospitalization. The neutrophil count is measured as part of the laboratory test, performed on the day of hospital admission, and carried out multiple times during hospitalizations. The absence of follow-up laboratory testing suggests clinical improvement. The abovementioned outcomes were extracted, as well as variables known or suspected to be associated with mastoiditis recovery or complications.
2 secondary outcomes
Evolution of complication rate of mastoiditis between January 2014 and July 2024
Time frame: From January 2014 to July 2024
Factors associated with complicated acute mastoïditis
Time frame: From January 2014 to July 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Mastoiditis, run by Cécile RUMEAU at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic factors of recovery in children hospitalized for mastoiditis in the region Grand-Est of France between 2014 and 2024 (time frame: From January 2014 to July 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.