SEINE: Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans

Sponsor

Centre Hospitalier Intercommunal Creteil (Other)

Overall Status

Recruiting

CT.gov ID

NCT04685850

Collaborator

Association Clinique Thérapeutique Infantile du val de Marne (Other)

100

Enrollment

Locations

23.2

Anticipated Duration (Months)

12.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Meningitis, Meningococcal Sequela	Other: sequela evaluation

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans in Ile de France: a Multidisciplinary Approach

Actual Study Start Date :

Jul 9, 2021

Anticipated Primary Completion Date :

Jan 15, 2023

Anticipated Study Completion Date :

Jun 15, 2023

Outcome Measures

Primary Outcome Measures

Number of children with at least one neurological, orthopedic or sensory sequelae [1 year]

Secondary Outcome Measures

Number of children with severe neurological sequelae [1 year]
Number of children with orthopedic complications [1 year]
Number of children with sensory disorders [1 year]
Number of children with skin sequelae [1 year]
Number of children with learning disabilities [1 year]
Number of children with cognitive or psychological difficulties identified on the WPPSI, WISC V or VINELAND depending on their age and capacity [1 year]
95% of the population has a Total IQ between 70 and 130 (from low intelligence to high intelligence).
Number of consultations during follow-up [1 year]
Post-traumatic stress in parents using the IES-R questionnaire [1 year]
A score up to 33 is associated with a stress post traumatic

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Child 1 to 15 years old who had meningococcal meningitis between 2010 and 2019
French health insurance

Exclusion Criteria:

refusal to participate

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH Argenteuil	Argenteuil	France	95107
2	CHU paris Sud site Antoine Béclère	Clamart	France	92140
3	CHI créteil	Créteil	France	94000
4	Groupe Hospitalier Nord Essonne	Longjumeau	France	91345
5	CH F Quesnay	Mantes-la-Jolie	France	78200
6	GHEF site de Meaux	Meaux	France	77100
7	Hôpital Necker Enfants Malades	Paris	France	75015
8	Robert debré hospital	Paris	France	75019

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil
Association Clinique Thérapeutique Infantile du val de Marne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Intercommunal Creteil

ClinicalTrials.gov Identifier:

NCT04685850

Other Study ID Numbers:

SEINE

First Posted:

Dec 28, 2020

Last Update Posted:

Aug 5, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Meningitis, Meningococcal

Meningitis

Purpura

Purpura Fulminans

Study Results

No Results Posted as of Aug 5, 2021