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

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ClinicalTrials.gov Identifier: NCT05981599
Recruitment Status : Recruiting
First Posted : August 8, 2023
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Meningococcal Infections 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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Epidemiological, Clinical and Biological Caracteristics of Patients Presenting With Invasive Meningococcal Disease in the West of France
Actual Study Start Date : June 30, 2023
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


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

Outcome Measures
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Primary Outcome Measures :
  1. Number of patient presenting with Invasive Meningococcal infection and its serogroup [ Time Frame: Two period of 18month, one when facial mask were recommanded, and one after ]
    - 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patient from the West part of France
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05981599


Contacts
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Contact: Romain Millot, Resident +33643002422 romain.millot@chu-poitiers.fr
Contact: France CAZENAVE ROBLOT, PhD +33549445454 france.cazenave-roblot@chu-poitiers.fr

Locations
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France
Poitiers University Recruiting
Poitiers, Vienne, France, 86000
Contact: France Cazenave Roblot, PhD    +33549445454    france.cazenave-roblot@chu-poitiers.fr   
Sponsors and Collaborators
Poitiers University Hospital
Investigators
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Study Director: France CAZENAVE ROBLOT, PhD SPILF
More Information
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Study Data/Documents: Actuality report  This link exits the ClinicalTrials.gov site
French Report on the epidemic situation of meningococcal disease in december 2022
Clinical Study Report  This link exits the ClinicalTrials.gov site

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT05981599    
Other Study ID Numbers: CARACIIM
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections