Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans

Recruiting

• Conditions: Sequela; Meningitis, Meningococcal

• Registration Number: NCT04685850
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Study Start: 2021-07-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2026-07-09
• Study Completion: 2026-07-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of children with at least one neurological, orthopedic or sensory sequelae	1 year

Secondary Outcome Measures

Name	Time	Method
Number of children with skin sequelae	1 year
Number of children with learning disabilities	1 year
Number of children with sensory disorders	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 children with severe neurological sequelae	1 year
Number of children with orthopedic complications	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
Number of consultations during follow-up	1 year

Trial Locations

Locations (9)

Centre Intercommunal de Villeneuve Saint Georges; 🇫🇷 Crosne, France

CHU Bicêtre; 🇫🇷 Le Kremlin Bicêtre, Kremlin Bicêtre, France

CHU Annecy; 🇫🇷 Annecy, France

CHI créteil; 🇫🇷 Créteil, France

Groupe Hospitalier Nord Essonne; 🇫🇷 Longjumeau, France

GHEF site de Meaux; 🇫🇷 Meaux, France

Ch Pontoise; 🇫🇷 Pontoise, France

Hôpital Necker Enfants Malades; 🇫🇷 Paris, France

Robert debré hospital; 🇫🇷 Paris, France