Meningitis, MeningococcalSEINENCT04685850
Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans
An observational study of Meningitis, Meningococcal and Sequela, run by Centre Hospitalier Intercommunal Creteil at 9 sites in France.
Trial summary
While the initial evolution of meningococcal meningitis (MM) is well described, there are few data on the long-term evolution, beyond 1 year. The objective of this research is to evaluate the sequelae of MM beyond 1 year in patients with a history of MM followed in Paris area, France. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Meningitis, Meningococcal, Sequela
- What is being tested?
- sequela evaluation
- How many people
- 43 participants
- Where
- 9 sitesFrance
- Study dates
- 9 Jul 2021to 19 May 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children from 0 to 17 years old who had meningococcal meningitis between 2010 and 2019
Who may be able to join
- Infants and children from 0 to 17 years old
- Having had meningitis or meningococcal purpura fulminans between 2010 and 2021
- Delay ≥ 1 year between the date of diagnosis of meningitis or purpura meningococcal fulminans and the date of inclusion in the study (signature of the informed consent)
- The holders of parental authority have read and understood the information letter and their express consent has been obtained
- Patient affiliated to a social security system (Social Security or Universal Medical Coverage)
Who cannot join
- refusal to participate
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU Annecy
Annecy, 74370
CHI créteil
Créteil, 94000
Centre Intercommunal de Villeneuve Saint Georges
Crosne, 91560
CHU Bicêtre
Le Kremlin-Bicêtre, Kremlin Bicêtre, 94720
Groupe Hospitalier Nord Essonne
Longjumeau, 91345
GHEF site de Meaux
Meaux, 77100
Hôpital Necker Enfants Malades
Paris, 75015
Robert debré hospital
Paris, 75019
Ch Pontoise
Pontoise, 95300
About this study
Official title: Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans in Ile de France: a Multidisciplinary Approach
While the initial evolution of meningococcal meningitis (MM) is well described, there are few data on the long-term evolution, beyond 1 year.
The objective of this research is to evaluate the sequelae of MM beyond 1 year in patients with a history of MM followed in Paris area, France. Most children with MM in France have been included in the MM register and are still being followed. Parents will be offered a detailed clinical evaluation of their child including: a clinical and neurological examination, a cognitive performance assessment, an auditory, speech and visual assessment and an evaluation of the child's progress at school.
- Conditions
- Meningitis, Meningococcal, Sequela
- Being tested
- sequela evaluation
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequela evaluationOther
clinical and neurological examination, psychological evaluation (cognitive performance), an auditory, speech and visual assessment and an evaluation of the child's school performance
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children with at least one neurological, orthopedic or sensory sequelae
Measured: 1 year
Secondary outcomes (8)
Number of children with severe neurological sequelae
Measured: 1 year
Number of children with orthopedic complications
Measured: 1 year
Number of children with sensory disorders
Measured: 1 year
Number of children with skin sequelae
Measured: 1 year
Number of children with learning disabilities
Measured: 1 year
Number of children with cognitive or psychological difficulties identified on the WPPSI, WISC V or VINELAND depending on their age and capacity
95% of the population has a Total IQ between 70 and 130 (from low intelligence to high intelligence).
Measured: 1 year
Number of consultations during follow-up
Measured: 1 year
Post-traumatic stress in parents using the IES-R questionnaire
A score up to 33 is associated with a stress post traumatic
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start9 Jul 2021
- Primary completion19 May 2025
- Study completion19 May 2025
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningitis, MeningococcalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Association Clinique Thérapeutique Infantile du val de Marne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685850
- Sponsor's protocol ID
- SEINE
- Acronym
- SEINE
- Status last verified
- Jun 2025
- First submitted
- 22 Dec 2020
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baloche A, Jung C, Levy M, Elbez-Rubinstein A, Bechet S, Layouni I, Monguillot G, Taha MK, Cohen R, Levy C. Long-term impact of invasive meningococcal disease in children: SEINE study protocol. PLoS One. 2022 May 26;17(5):e0268536. doi: 10.1371/journal.pone.0268536. eCollection 2022.
PubMed 35617288
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans in Ile de France: a Multidisciplinary Approach
- ClinicalTrials.gov ID
- NCT04685850
- Acronym / sponsor ID
- SEINE / SEINE
- Conditions
- Meningitis, Meningococcal, Sequela
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Association Clinique Thérapeutique Infantile du val de Marne
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 28 Dec 2020 (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.
While the initial evolution of meningococcal meningitis (MM) is well described, there are few data on the long-term evolution, beyond 1 year.
The objective of this research is to evaluate the sequelae of MM beyond 1 year in patients with a history of MM followed in Paris area, France. Most children with MM in France have been included in the MM register and are still being followed. Parents will be offered a detailed clinical evaluation of their child including: a clinical and neurological examination, a cognitive performance assessment, an auditory, speech and visual assessment and an evaluation of the child's progress at school.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children from 0 to 17 years old who had meningococcal meningitis between 2010 and 2019
Key inclusion criteria (5 listed)
- Infants and children from 0 to 17 years old
- Having had meningitis or meningococcal purpura fulminans between 2010 and 2021
- Delay ≥ 1 year between the date of diagnosis of meningitis or purpura meningococcal fulminans and the date of inclusion in the study (signature of the informed consent)
- The holders of parental authority have read and understood the information letter and their express consent has been obtained
- Patient affiliated to a social security system (Social Security or Universal Medical Coverage)
Key exclusion criteria (1 listed)
- refusal to participate
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 |
|---|---|---|
| sequela evaluationclinical and neurological examination, psychological evaluation (cognitive performance), an auditory, speech and visual assessment and an evaluation of the child's school performance | Other | – |
Primary outcome
Number of children with at least one neurological, orthopedic or sensory sequelae
Time frame: 1 year
8 secondary outcomes
Number of children with severe neurological sequelae
Time frame: 1 year
Number of children with orthopedic complications
Time frame: 1 year
Number of children with sensory disorders
Time frame: 1 year
Number of children with skin sequelae
Time frame: 1 year
Number of children with learning disabilities
Time frame: 1 year
Number of children with cognitive or psychological difficulties identified on the WPPSI, WISC V or VINELAND depending on their age and capacity
Time frame: 1 year
Number of consultations during follow-up
Time frame: 1 year
Post-traumatic stress in parents using the IES-R questionnaire
Time frame: 1 year
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Derived from this study: PubMed 35617288Baloche A, Jung C, Levy M, Elbez-Rubinstein A, Bechet S, Layouni I, Monguillot G, Taha MK, Cohen R, Levy C. Long-term impact of invasive meningococcal disease in children: SEINE study protocol. PLoS One. 2022 May 26;17(5):e0268536. doi: 10.1371/journal.pone.0268536. eCollection 2022.
- Long-term impact of invasive meningococcal disease in children: SEINE study protocolLink provided by the sponsor.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis, Meningococcal and Sequela, run by Centre Hospitalier Intercommunal Creteil at 9 sites 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 5 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: stopped early, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 was stopped early (reason given: lack of inclusion). Results are not available in the source record.
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?
Number of children with at least one neurological, orthopedic or sensory sequelae (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04685850, which also lists 1 linked publication.
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 13 Jun 2025.