Epidemiological, Clinical and Biological Caracteristics of Patients Presenting With Invasive Meningococcal Disease

Meningococcal Infections Clinical Trial

— CARACIIM  

Official title:

Epidemiological, Clinical and Biological Caracteristics of Patients Presenting With Invasive Meningococcal Disease in the West of France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981599
• Other study ID #: CARACIIM
• Status: Recruiting
• Start date: June 30, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2023
• Source: Poitiers University Hospital
• Contact: Romain Millot, Resident
• Phone: +33643002422
• Email: romain.millot[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An unusual increase in cases of invasive meningococcal infection between late 2022 and early 2023. These cases sometimes had atypical presentations (large numbers of bacteremias without meningitis). The distribution of serogroups was also unusual in our center (large number of serotype Y meningococcal IMD).

This development comes after three years marked by the Corona-Virus-Disease-19 pandemic, which led to a profound change in the behaviors involved in the transmission of infectious diseases. Barrier measures have considerably reduced the population's exposure to meningococcus, and may have encouraged a reduction in mucosal immunity to this pathogen. The end of 2022 was also marked by intense viral circulation (syncitial respiratory virus-influenza-COVID), which may have favored invasive forms.

Description:

Invasive meningococcal disease (IMD) accounts for a small number of cases (500-600 cases/year) in mainland France. Despite advances in its management, the disease is still associated with a 10-20% mortality rate and impaired quality of life in 50% of surviving patients.

An unusual increase in cases of invasive meningococcal infection during the winter of 2022. These cases often had atypical presentations (large number of bacteremias without meningitis, digestive picture in the foreground). The distribution of serogroups was also unusual at our center (large number of serotype Y meningococcal IMD). These data appear to be confirmed by Santé Publique France's national data for 2022, with no warning of the spread of a hyper-virulent clone.

This development comes after three years marked by the SARS-CoV2 pandemic, which led to a profound change in the behaviors involved in the transmission of infectious diseases .

Barrier measures have considerably reduced the population's exposure to meningococcus, and may have led to a reduction in mucosal immunity to this pathogen. This is particularly true of teenagers and young adults, for whom contact has fallen sharply due to the closure of schools and universities. It would be interesting to see whether this population is more affected this year than in previous years.

The end of 2022 was also marked by intense viral circulation (SRV-Flu-Covid), which could have favored invasive forms. Evidence of a significant number of viral co-infections could support this hypothesis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Clinical diagnosis of Invasive Meningococcal infection (defined by the isolation of Neisseria meningitis in a normaly steril site (CSL, blood, articulation, ..) by PCR or culture.

No exclusion Criteria

Related Conditions & MeSH terms

• Meningococcal Infections

Intervention

Other:
• There is no intervention
There is no intervention. Only retrieving clinical, biological and epidemiological data from patient files

Locations

Country	Name	City	State
France	Poitiers University	Poitiers	Vienne

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient presenting with Invasive Meningococcal infection and its serogroup	- Evolution of the Number of case according to time and the evolution of serogroup There will be two study period. The number of Invasive Meningococcal infection and their serogroup will be counted in each period.	Two period of 18month, one when facial mask were recommanded, and one after