Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans

Meningitis, Meningococcal Clinical Trial

— SEINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04685850
• Other study ID #: SEINE
• Status: Recruiting
• Start date: July 9, 2021
• Est. completion date: July 9, 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Robert COHEN
• Phone: 01 43 97 02 97
• Email: robert.cohen[@]activ-france.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 9, 2026
• Est. primary completion date: July 9, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Purpura
• Purpura Fulminans
• Sequela

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	CHU Annecy	Annecy
France	CHI créteil	Créteil
France	Centre Intercommunal de Villeneuve Saint Georges	Crosne
France	CHU Bicêtre	Le Kremlin Bicêtre	Kremlin Bicêtre
France	Groupe Hospitalier Nord Essonne	Longjumeau
France	GHEF site de Meaux	Meaux
France	Hôpital Necker Enfants Malades	Paris
France	Robert debré hospital	Paris
France	Ch Pontoise	Pontoise

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of children with at least one neurological, orthopedic or sensory sequelae		1 year
Secondary	Number of children with severe neurological sequelae		1 year
Secondary	Number of children with orthopedic complications		1 year
Secondary	Number of children with sensory disorders		1 year
Secondary	Number of children with skin sequelae		1 year
Secondary	Number of children with learning disabilities		1 year
Secondary	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).	1 year
Secondary	Number of consultations during follow-up		1 year
Secondary	Post-traumatic stress in parents using the IES-R questionnaire	A score up to 33 is associated with a stress post traumatic	1 year

External Links

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