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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Meningococcal Infections
• Intervention / Treatment: Other: There is no intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Romain Millot, Resident; Phone Number: +33643002422; Email: romain.millot@chu-poitiers.fr
• Study Contact Backup: Name: France Cazenave Roblot, PhD; Phone Number: +33549445454; Email: france.cazenave-roblot@chu-poitiers.fr

Study Locations

• France
  • Vienne
    • Poitiers, Vienne, France, 86000
      • Recruiting
      • Poitiers University
      • Contact: France Cazenave Roblot, PhD; Phone Number: +33549445454; Email: france.cazenave-roblot@chu-poitiers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patient from the West part of France

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Study Director: France CAZENAVE ROBLOT, PhD, SPILF

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): August 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: CARACIIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Study Data/Documents

1. Actuality report
   Information comments: French Report on the epidemic situation of meningococcal disease in december 2022
2. Clinical Study Report

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No