Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans

NCT ID: NCT04685850

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-09

Study Completion Date

2025-05-19

Brief Summary

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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.

Detailed Description

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Conditions

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Meningitis, Meningococcal Sequela

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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sequela evaluation

clinical and neurological examination, psychological evaluation (cognitive performance), an auditory, speech and visual assessment and an evaluation of the child's school performance

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* refusal to participate
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association Clinique Thérapeutique Infantile du val de Marne

OTHER

Sponsor Role collaborator

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Bicêtre

Le Kremlin-Bicêtre, Kremlin Bicêtre, France

Site Status

CHU Annecy

Annecy, , France

Site Status

CHI créteil

Créteil, , France

Site Status

Centre Intercommunal de Villeneuve Saint Georges

Crosne, , France

Site Status

Groupe Hospitalier Nord Essonne

Longjumeau, , France

Site Status

GHEF site de Meaux

Meaux, , France

Site Status

Hôpital Necker Enfants Malades

Paris, , France

Site Status

Robert debré hospital

Paris, , France

Site Status

Ch Pontoise

Pontoise, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 35617288 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/35617288/

Long-term impact of invasive meningococcal disease in children: SEINE study protocol

Other Identifiers

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SEINE

Identifier Type: -

Identifier Source: org_study_id

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